http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
The Small Company Clinical Study SponsorRoles & Duties Vis-à-vis LiabilityMichael Swit
This document summarizes a presentation given by Michael Swit on roles and responsibilities of small company clinical trial sponsors and how to minimize liability when outsourcing clinical trial activities. Key points discussed include clarifying what sponsors are responsible for versus outsourcing partners, ensuring compliance of outsourcing partners, maintaining oversight of critical trial activities in-house, and explaining to funders that quality must be prioritized over cost.
This document summarizes a presentation about FDA regulation of biosimilars. It discusses how biosimilars differ from traditional generics due to biologics being more complex molecules than small molecule drugs. It outlines the key provisions of the Biologics Price Competition and Innovation Act of 2009, including requirements for biosimilar applications such as analytical, animal and clinical studies demonstrating biosimilarity to the reference product. It also discusses requirements for interchangeability and other miscellaneous rules regarding biosimilar approval pathways.
FDA Enforcement & Compliance for Medical DevicesMichael Swit
Presentation to the Food & Drug Law Institute (FDLI) Introduction to Medical Device Law, with a focus on:
* FDA Jurisdiction to Enforce
* Prohibited Acts and Penalties
* Inspections – FDA’s Prime Enforcement Tool
* Other “Cops on the Beat”
* Commissioner Hamburg’s Enforcement Initiative
I delivered this presentation at the DTC National Conference in Washington DC. The presentation highlights the importance of mobile for people making decisions about their health and discusses how to present information about FDA-regulated products in this important channel.
Quality Considerations in Due Diligence for Pharmaceutical TransactionsMichael Swit
The document discusses quality considerations in due diligence for pharmaceutical transactions. It outlines general considerations for due diligence structure and challenges. It emphasizes that quality matters because drugs made in non-compliant facilities can be considered adulterated by the FDA and result in criminal and civil penalties. The document provides examples of problems to look for, including manufacturing, pharmacovigilance, compliance history, FDA inspection history, and audits. It discusses techniques for probing issues, including reviewing FDA correspondence and litigation. Special considerations are outlined for different drug development stages. Helpful charts on diligence issues by stage and analyzing identified issues are presented.
http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
The Small Company Clinical Study SponsorRoles & Duties Vis-à-vis LiabilityMichael Swit
This document summarizes a presentation given by Michael Swit on roles and responsibilities of small company clinical trial sponsors and how to minimize liability when outsourcing clinical trial activities. Key points discussed include clarifying what sponsors are responsible for versus outsourcing partners, ensuring compliance of outsourcing partners, maintaining oversight of critical trial activities in-house, and explaining to funders that quality must be prioritized over cost.
This document summarizes a presentation about FDA regulation of biosimilars. It discusses how biosimilars differ from traditional generics due to biologics being more complex molecules than small molecule drugs. It outlines the key provisions of the Biologics Price Competition and Innovation Act of 2009, including requirements for biosimilar applications such as analytical, animal and clinical studies demonstrating biosimilarity to the reference product. It also discusses requirements for interchangeability and other miscellaneous rules regarding biosimilar approval pathways.
FDA Enforcement & Compliance for Medical DevicesMichael Swit
Presentation to the Food & Drug Law Institute (FDLI) Introduction to Medical Device Law, with a focus on:
* FDA Jurisdiction to Enforce
* Prohibited Acts and Penalties
* Inspections – FDA’s Prime Enforcement Tool
* Other “Cops on the Beat”
* Commissioner Hamburg’s Enforcement Initiative
I delivered this presentation at the DTC National Conference in Washington DC. The presentation highlights the importance of mobile for people making decisions about their health and discusses how to present information about FDA-regulated products in this important channel.
Quality Considerations in Due Diligence for Pharmaceutical TransactionsMichael Swit
The document discusses quality considerations in due diligence for pharmaceutical transactions. It outlines general considerations for due diligence structure and challenges. It emphasizes that quality matters because drugs made in non-compliant facilities can be considered adulterated by the FDA and result in criminal and civil penalties. The document provides examples of problems to look for, including manufacturing, pharmacovigilance, compliance history, FDA inspection history, and audits. It discusses techniques for probing issues, including reviewing FDA correspondence and litigation. Special considerations are outlined for different drug development stages. Helpful charts on diligence issues by stage and analyzing identified issues are presented.
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
This document summarizes alternative approaches for obtaining FDA approval for drugs and devices, including Subpart E regulations, accelerated approval, fast track designation, breakthrough therapy designation, and FDA's review priority system. It discusses provisions of each pathway that aim to expedite development and review, such as early consultation meetings, approval based on surrogate endpoints, and rolling review of applications. The document also provides explanations and examples of key terms used in these pathways.
Webinar or Online Training on A comprehensive overview of 510(k) submissionComplianz World
Complianz World is a US based company, and a leading GRC training provider has announced to conduct
Webinar or Online Training on
A comprehensive overview of 510(k) submission
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
So what's the risk using 3rd party suppliers?Drexel White
A brief overview focusing on risks associated with using uncertified suppliers and non-compliant hardware with a few precautionary measures organizations should adopt.
Drexel has lead or managed aerospace/defense industry teams and organizations supporting several critical US programs and actions; JLENS, XBR, BMDS, THAAD, TOW, STRYKER, PATRIOT, EFOGM, Maverick Missile, Standard Missile, Persian Gulf War and War on Terrorism in System Safety Engineering, IV&V, Environmental Testing, Live Fire and All-Up Round Operations management.
GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...Michael Swit
Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.
Quality system regulation equipment and facilities controls subsystem.OnlineCompliance Panel
The FDA's Quality System Inspection Technique (QSIT) inspectional methodology "divides" the requirements for medical device manufacturers into seven subsystems; one of those is the Equipment and Facilities Controls subsystem. The purpose of the Equipment and Facilities Controls (E&FC) requirements of the Quality System Regulation (QSR) is to ensure that adequate equipment and facilities are available and maintained for manufacturers to produce and store devices that conform to their specifications and reduce the potential for contamination of those products.
This webinar will provide an explanation of the regulatory requirements for facilities and equipment that must be followed by medical device manufacturers in the manufacture and storage of their products, beginning with an overview of QSIT and an in-depth review of the elements included in E & FC.
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
FDA Enforcement: The Cop is Back – How Enhanced Enforcement Can Impact You a...Michael Swit
December 15, 2010 webinar sponsored by The Weinberg Group on increased FDA enforcement activity under the Obama administration, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
Key FDA Enforcement Actions
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA’s Record under Enhanced Compliance
Compliant Promotion in an On-demand WorldDale Cooke
The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has proven challenging and confusing for companies not accustomed to digital tactics.
* Recent FDA enforcement actions that command the attention of anyone considering digital communication tactics
* Trends in digital media consumption and their impact on advertising effectiveness
* FDA’s 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
* FDA’s 2011 Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
*Some red flags guaranteed to draw FDA’s ire
* The latest on FDA social media guidance
GCP Enforcement Trends Lessons Learned from FDA Inspections of Sponsors, Site...Michael Swit
July 21, 2015 Webinar sponsored by FDANews.com, with a focus on:
* How to avoid enforcement by complying
* FDA statistics on enforcement actions in the clinical research arena
* Key observations by sponsor, IRB, and investigator
Now you don’t need to take any stress about the RAC US Exam. We provide you real exam questions along with updated Test Engine. You can pass your exam in first attempt with 100% passing assurance and money back guarantee. Get amazing flat 15% discount on RAC US exam and pass your RAC US Dumps Exam. Visit us for more information and RAC US Exam Questions.
https://www.certs4you.com/raps/rac-us-dumps.html
Recent FDA Developments in Digital Health & Clinical Decision Support SoftwareMichael Swit
June 7, 2018 presentation at the 4th Annual Medical Device Summit, sponsored by ComplianceOnline, in San Francisco, focusing on the impact of the 21st Century Cures Act and other developments on how FDA regulates software in the medical device arena, including mobile medical applications.
Marketing, Advertising and Promotion of Pharmaceuticals and Medical DevicesGlobalCompliancePanel
The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA").
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
FDA Regulatory Considerations for the Biomedical CompaniesMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in October 2007 on how to develop FDA-regulated products, with a focus on planning, working with FDA, regulatory pitfalls, clinical studies, etc.
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
This document summarizes alternative approaches for obtaining FDA approval for drugs and devices, including Subpart E regulations, accelerated approval, fast track designation, breakthrough therapy designation, and FDA's review priority system. It discusses provisions of each pathway that aim to expedite development and review, such as early consultation meetings, approval based on surrogate endpoints, and rolling review of applications. The document also provides explanations and examples of key terms used in these pathways.
Webinar or Online Training on A comprehensive overview of 510(k) submissionComplianz World
Complianz World is a US based company, and a leading GRC training provider has announced to conduct
Webinar or Online Training on
A comprehensive overview of 510(k) submission
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
The Other Agency: An introduction to Pharma MarketingDale Cooke
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
So what's the risk using 3rd party suppliers?Drexel White
A brief overview focusing on risks associated with using uncertified suppliers and non-compliant hardware with a few precautionary measures organizations should adopt.
Drexel has lead or managed aerospace/defense industry teams and organizations supporting several critical US programs and actions; JLENS, XBR, BMDS, THAAD, TOW, STRYKER, PATRIOT, EFOGM, Maverick Missile, Standard Missile, Persian Gulf War and War on Terrorism in System Safety Engineering, IV&V, Environmental Testing, Live Fire and All-Up Round Operations management.
GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...Michael Swit
Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.
Quality system regulation equipment and facilities controls subsystem.OnlineCompliance Panel
The FDA's Quality System Inspection Technique (QSIT) inspectional methodology "divides" the requirements for medical device manufacturers into seven subsystems; one of those is the Equipment and Facilities Controls subsystem. The purpose of the Equipment and Facilities Controls (E&FC) requirements of the Quality System Regulation (QSR) is to ensure that adequate equipment and facilities are available and maintained for manufacturers to produce and store devices that conform to their specifications and reduce the potential for contamination of those products.
This webinar will provide an explanation of the regulatory requirements for facilities and equipment that must be followed by medical device manufacturers in the manufacture and storage of their products, beginning with an overview of QSIT and an in-depth review of the elements included in E & FC.
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
FDA Enforcement: The Cop is Back – How Enhanced Enforcement Can Impact You a...Michael Swit
December 15, 2010 webinar sponsored by The Weinberg Group on increased FDA enforcement activity under the Obama administration, with a focus on:
Enforcement Trends Prior to Obama Administration
Commissioner Hamburg Revives FDA’s Compliance Culture –The August 6, 2009 Speech and its Impact
Key FDA Enforcement Actions
How to Prepare for Increased Enforcement
How to Respond if Targeted
Consequences of Non-Compliance
FDA’s Record under Enhanced Compliance
Compliant Promotion in an On-demand WorldDale Cooke
The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has proven challenging and confusing for companies not accustomed to digital tactics.
* Recent FDA enforcement actions that command the attention of anyone considering digital communication tactics
* Trends in digital media consumption and their impact on advertising effectiveness
* FDA’s 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
* FDA’s 2011 Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
*Some red flags guaranteed to draw FDA’s ire
* The latest on FDA social media guidance
GCP Enforcement Trends Lessons Learned from FDA Inspections of Sponsors, Site...Michael Swit
July 21, 2015 Webinar sponsored by FDANews.com, with a focus on:
* How to avoid enforcement by complying
* FDA statistics on enforcement actions in the clinical research arena
* Key observations by sponsor, IRB, and investigator
Now you don’t need to take any stress about the RAC US Exam. We provide you real exam questions along with updated Test Engine. You can pass your exam in first attempt with 100% passing assurance and money back guarantee. Get amazing flat 15% discount on RAC US exam and pass your RAC US Dumps Exam. Visit us for more information and RAC US Exam Questions.
https://www.certs4you.com/raps/rac-us-dumps.html
Recent FDA Developments in Digital Health & Clinical Decision Support SoftwareMichael Swit
June 7, 2018 presentation at the 4th Annual Medical Device Summit, sponsored by ComplianceOnline, in San Francisco, focusing on the impact of the 21st Century Cures Act and other developments on how FDA regulates software in the medical device arena, including mobile medical applications.
Marketing, Advertising and Promotion of Pharmaceuticals and Medical DevicesGlobalCompliancePanel
The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA").
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
FDA Regulatory Considerations for the Biomedical CompaniesMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in October 2007 on how to develop FDA-regulated products, with a focus on planning, working with FDA, regulatory pitfalls, clinical studies, etc.
Drug Safety: Perspectives on Industry's Duties in the Post-Vioxx Age.Michael Swit
Presentation to the Food & Drug Law Institute (FDLI) on Drug Safety with commentary on what are the emerging duties that industry may have to undertake in order to stay ahead of safety issues and avoid related products liability exposure.
FDA Trends in Medical Device ComplianceMichael Swit
Presentation to the Joint American Bar Association (ABA)/Medical Device Manufacturers Association (MDMA) Conference, on December 11, 2014, in Washington, D.C.. Slides focus on:
• Major Initiatives –
– Inspection Realignment
– Reporting of Corrections Guidance
• FDA Inspections –Key Observations in Device Inspections
• Marketing & Social Media –
– Intended Use Creep --Aegerion
– Space Limitation Guidance
• HHS Exclusion for FDA Violations –the Curious Case of the Purdue Pharma Executives
The Small Company Clinical Study Sponsor -- Roles & Duties Vis-à-vis LiabilityMichael Swit
September 24, 2014 presentation to the Outsourcing in Clinical Trials: Southern California Conference, sponsored by Arena Conferences, focusing on:
* Clarifying exactly what you are responsible for and what you made be held accountable for
* Analyzing degrees of liability between bigger and smaller companies
* Ensuring that you are enforcing compliance from your outsourcing partners to avoid repercussions on yourselves
* Determining aspects of your trial management that you should retain in-house as a minimum so as to avoid liability issues
* Explaining to funders why quality and risk-assessments are a necessary expenditure above the cheapest options
Presentation at FDLI 49th Annual Conference, with a focus on how key issues, including products liability concerns in the wake of the Vioxx withdrawal, may impact future FDA and related compliance issues.
The Application Integrity Policy (AIP): A Little HistoryMichael Swit
Presentation to March 13, 2018 webinar sponsored by the Food & Drug Law Institute (FDLI) on Data Integrity, in which I reviewed the origins of the AIP and its role in FDA's enforcement armamentarium.
A FDA Crisis History -- The Generic Drug ScandalMichael Swit
Webinar given to the Regulatory Affairs Professionals Society (RAPS) Rising Leaders Program using a case study of the generic drug scandal as a basis to understanding how to react to a scandal, SEC disclosure duties, collateral consequences of a crisis, and lessons learned.
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
This document summarizes a presentation on responding to FDA inspections and warning letters. It discusses Commissioner Hamburg's 2009 speech that revived FDA's compliance culture and enforcement efforts. It outlines FDA's expectations for timely responses to Form 483 observations and warning letters. It provides tips for how companies can prepare for and handle inspections, including designating personnel roles and training employees. It also offers guidance on writing effective responses to Form 483s and warning letters that address each violation, present corrective actions, and minimize future regulatory risks.
Regulatory Considerations in Product DevelopmentMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in November 2011 on how to develop FDA-regulated products, with a focus on planning, working with FDA,
FDA Regulatory Considerations for the Biomedical Start-upMichael Swit
October 7, 2005 presentation to the LARTA CAP program in Newport Beach, CA, focusing on:
* 3 key roles of FDA
* tips for the unwary
* regulatory definitions
* submission types
* data required for approval
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
June 24, 2015 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focus:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ Cosmetic Regulation
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
August 7, 2013 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
The Application Integrity Policy (AIP): A Little History.Michael Swit
This document summarizes the FDA's Application Integrity Policy (AIP), which was established in 1991 in response to fraud in generic drug applications. The AIP allows the FDA to defer review of any application where they have questions about the reliability of the data, until those questions are resolved. Companies that fall under the AIP must cooperate with investigators, identify wrongdoers, conduct an internal review, and submit a corrective action plan signed by the CEO to address procedures and controls to prevent future issues. Few companies have survived being placed on the AIP, as it often coincides with criminal prosecution and civil litigation that can damage a company.
The “De Novo” 510(k) Process and the Reclassification of Class III DevicesMichael Swit
September 30, 2005 presentation to the Medical Device Manufacturers Association (MDMA) 510(k) Workshop, in Burlington, MA, with a focus on how the de novo process evolved, challenges faced by those seeking to pursue it, and how it has evolved since FDAMA.
FDA Approval for Medical Devices: A Guide for Entrepreneurs | Jim Gustafson |...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
The De Novo 510(k) Process - Is There Hope at FDA for Lower Risk Innovative D...Michael Swit
This document summarizes a presentation given by Michael Swit on the FDA's de novo classification process for novel medical devices. It discusses the origins of the de novo pathway, how devices become eligible for de novo review, and the two approaches outlined in a recent draft guidance (pre-de novo submission and traditional petition). It provides details on the format and timing for a pre-de novo submission and de novo petition, as well as how FDA reviews and responds to each. Statistics on de novo petitions approved from 1998-2011 are also presented, broken down by therapeutic area and year. Finally, special controls commonly required as part of the de novo process are summarized.
Regulatory & Quality Considerations in Virtual Drug DevelopmentMichael Swit
Presentation to Strategies for Success in Virtual Drug Development Conference on April 15, 2013, in San Diego, focusing on:
• General Considerations
• Why Quality & Regulatory Matter
• What Problems to Look For
• How to Find Problems
• Special Considerations
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Lab...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 5: Social Media & InternetMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Action...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientific...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer AdsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
Presentation on Critical Legal Issues Facing GMP ComplianceMichael Swit
August 27, 2018 Presentation to the 23rd Annual GMP by the Sea Conference in Cambridge, Maryland, focusing on the potential legal consequences faced by companies that violate FDA's requirements on Good Manufacturing Practices (GMPs) for drugs and biologics
Overview of FDA Drug Manufacturing RequirementsMichael Swit
Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.
Combination Products, Orphan Drugs, and OTC DrugsMichael Swit
Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs.
June 14, 2018 presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Review Course on the basics of FDA regulation of generic drugs and biosimilars.
FDA Inspections: Handling the Consequences -- or Understanding How Ugly It C...Michael Swit
Presentation to the MAGI Clinical Research Conference – 2018 East, given on May 22, 2018 in Arlington, Virginia, and focusing on the collateral consequences of negative FDA inspections in the clinical research arena
What’s In a Name? FDA and Non-Proprietary Names for Biologics/BiosimilarsMichael Swit
April 20, 2018 Presentation to the 11th Biosimilars & Follow-On Biologics 2018 Americas conference on FDA's Policy on Non-proprietary names for Biosimilars
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Co...Michael Swit
This document summarizes a training session on handling promotional compliance at the company level. It discusses that companies need a system with procedures, training, records, audits and validation. It also recommends having a team that includes medical, R&D, regulatory, labeling, marketing, legal, and compliance review promotional materials. Additionally, it outlines key measures companies can take to protect themselves, including implementing an effective compliance program with written policies, a compliance officer, training programs, auditing, and responding promptly to any issues.
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-La...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 23, 2018
FDA Regulation of Promotion & Advertising -- Part 5: Social Media & InternetMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Actio...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
This document briefly explains the June compliance calendar 2024 with income tax returns, PF, ESI, and important due dates, forms to be filled out, periods, and who should file them?.
The Future of Criminal Defense Lawyer in India.pdfveteranlegal
https://veteranlegal.in/defense-lawyer-in-india/ | Criminal defense Lawyer in India has always been a vital aspect of the country's legal system. As defenders of justice, criminal Defense Lawyer play a critical role in ensuring that individuals accused of crimes receive a fair trial and that their constitutional rights are protected. As India evolves socially, economically, and technologically, the role and future of criminal Defense Lawyer are also undergoing significant changes. This comprehensive blog explores the current landscape, challenges, technological advancements, and prospects for criminal Defense Lawyer in India.
सुप्रीम कोर्ट ने यह भी माना था कि मजिस्ट्रेट का यह कर्तव्य है कि वह सुनिश्चित करे कि अधिकारी पीएमएलए के तहत निर्धारित प्रक्रिया के साथ-साथ संवैधानिक सुरक्षा उपायों का भी उचित रूप से पालन करें।
Lifting the Corporate Veil. Power Point Presentationseri bangash
"Lifting the Corporate Veil" is a legal concept that refers to the judicial act of disregarding the separate legal personality of a corporation or limited liability company (LLC). Normally, a corporation is considered a legal entity separate from its shareholders or members, meaning that the personal assets of shareholders or members are protected from the liabilities of the corporation. However, there are certain situations where courts may decide to "pierce" or "lift" the corporate veil, holding shareholders or members personally liable for the debts or actions of the corporation.
Here are some common scenarios in which courts might lift the corporate veil:
Fraud or Illegality: If shareholders or members use the corporate structure to perpetrate fraud, evade legal obligations, or engage in illegal activities, courts may disregard the corporate entity and hold those individuals personally liable.
Undercapitalization: If a corporation is formed with insufficient capital to conduct its intended business and meet its foreseeable liabilities, and this lack of capitalization results in harm to creditors or other parties, courts may lift the corporate veil to hold shareholders or members liable.
Failure to Observe Corporate Formalities: Corporations and LLCs are required to observe certain formalities, such as holding regular meetings, maintaining separate financial records, and avoiding commingling of personal and corporate assets. If these formalities are not observed and the corporate structure is used as a mere façade, courts may disregard the corporate entity.
Alter Ego: If there is such a unity of interest and ownership between the corporation and its shareholders or members that the separate personalities of the corporation and the individuals no longer exist, courts may treat the corporation as the alter ego of its owners and hold them personally liable.
Group Enterprises: In some cases, where multiple corporations are closely related or form part of a single economic unit, courts may pierce the corporate veil to achieve equity, particularly if one corporation's actions harm creditors or other stakeholders and the corporate structure is being used to shield culpable parties from liability.
Receivership and liquidation Accounts
Being a Paper Presented at Business Recovery and Insolvency Practitioners Association of Nigeria (BRIPAN) on Friday, August 18, 2023.
Matthew Professional CV experienced Government LiaisonMattGardner52
As an experienced Government Liaison, I have demonstrated expertise in Corporate Governance. My skill set includes senior-level management in Contract Management, Legal Support, and Diplomatic Relations. I have also gained proficiency as a Corporate Liaison, utilizing my strong background in accounting, finance, and legal, with a Bachelor's degree (B.A.) from California State University. My Administrative Skills further strengthen my ability to contribute to the growth and success of any organization.
Synopsis On Annual General Meeting/Extra Ordinary General Meeting With Ordinary And Special Businesses And Ordinary And Special Resolutions with Companies (Postal Ballot) Regulations, 2018
Sangyun Lee, 'Why Korea's Merger Control Occasionally Fails: A Public Choice ...Sangyun Lee
Presentation slides for a session held on June 4, 2024, at Kyoto University. This presentation is based on the presenter’s recent paper, coauthored with Hwang Lee, Professor, Korea University, with the same title, published in the Journal of Business Administration & Law, Volume 34, No. 2 (April 2024). The paper, written in Korean, is available at <https://shorturl.at/GCWcI>.
Genocide in International Criminal Law.pptxMasoudZamani13
Excited to share insights from my recent presentation on genocide! 💡 In light of ongoing debates, it's crucial to delve into the nuances of this grave crime.
Defending Weapons Offence Charges: Role of Mississauga Criminal Defence LawyersHarpreetSaini48
Discover how Mississauga criminal defence lawyers defend clients facing weapon offence charges with expert legal guidance and courtroom representation.
To know more visit: https://www.saini-law.com/
2. 2
Standard Disclaimers
• Views expressed here are solely mine and do not
reflect those of my firm or any of its clients.
• This presentation supports an oral briefing and
may not be relied upon solely on its own to
reach any conclusion of law or fact.
3. 3
“Global” Environment
• Obama Administration – what does it foretell
– Universal health care …?
• FDA Issues
– New commissioner – who, biases/predilections
• Sharfstein – ex-Waxman staffer
• Califf – Duke – cardiologist; head of Duke Clinical
Research Institute – colleagues, e.g., Mitchell Krucoff;
significant experience with CV devices
4. 4
FDA Environment
• CDRH – under fire by Capitol Hill – coercion of
reviewers by upper management – impact???
– Changes at the top?
• CDRH Director– staying? House in New Mexico
• ODE Director – also “implicated”
– Disruption of review process
– A prolonged Congressional inquiry can be very disruptive in
general as diverts resources
– Pressures FDA to be much more conservative – e.g., device
companies may be required to submit IDEs and resultant
clinical data to support the 510(k) process
• Alpert – agrees -- more data less risk tolerance.
5. 5
Device Approval/Marketing Issues
• 510k Process
– GAO report – required by FDAAA
• Includes a focus on FDA’s failure to require PMAs or reclassify a number of
pre-’76 devices in CV area as required by the 1990 Safe Medical Devices Act
– Types:
» external pacemaker pulse generator (870.3600),
» Permanent pacemaker electrodes (870.3680)
» External cardiac compressor (870.5200)
» AED – automated external defibrillator (870.5310)
» Nonroller-type cardiopulmonary bypass blood pump (870.4360)
– Class III devices being cleared under 510k – 27 % were CV devices
– If put in Class III, PMA’s will be needed
• Focuses on “High risk device” should be under PMA
• New intended uses – only found in 1% of 510k’s
• New tech. characteristics – only found in 15%
6. 6
Device Approval/Marketing Issues …
• Anticipate more demand for clinical data for Class II
devices
• Clinical studies – already hard; could get harder
– Proposed Physicians Sunshine Act would require physicians to
post the disclosure on a federally run website and if they do
not file the fine is pretty hefty. $10,000/day.
• Disincentive to be an investigator?
• Inspections – there is legislative language on Capitol
Hill that would require an inspection for every 510k
7. 7
FDA Concerns – Devices in General
• Submission Issues
– Normative data
• Quality Issues -- Compliance
– Design controls
– Software processes and validation
– Foreign facilities – if you have them, make sure they
are up to snuff – import detention is too easy
8. 8
Post-Market Issues
• Expect more post market requirements
• Expect greater scutiny of MDRs as issues.
• Mandatory registries are an initiative that may be
the problem
• Preemption – keep an eye on Congress
9. 9
Unique Device Identification
• FDA has published a notice in the Federal Register announcing a Public Workshop
on 12 February 2009 and requesting comments on a number of UDI related
issues. Please see: Docket No. FDA-2008-N-0661, CDRH 200866. Unique Device
Identification System; Public Workshop; Request for Comments. Comments due
February 27, 2009.
• Upcoming Meeting: FDA Unique Device Identification Public Workshop:
February 12, 2009
• On September 27, 2007, the Food and Drug Administration Amendments Act of
2007 was signed into law. This act includes language related to the establishment
of a Unique Device Identification System. This new system when implemented
will require:
– the label of a device to bear a unique identifier, unless an alternative location is
specified by FDA or unless an exception is made for a particular device or group of
devices.
– the unique identifier to be able to identify the device through distribution and use
– the unique identifier to include the lot or serial number if specified by FDA
10. 10
An Invitation
• Webinar – tomorrow morning – Ten Chief
Obstacles to Meeting Your Development
Milestones – 8 am PT
– www.weinberggroup.com
11. 11
Call, e-mail, fax or write:
Michael A. Swit, Esq.
Vice President, Life Sciences
THE WEINBERG GROUP INC.
336 North Coast Hwy. 101
Suite C
Encinitas, CA 92024
Phone 760.633.3343
Fax 760.454.2979
Cell 760.815.4762
michael.swit@weinberggroup.com
www.weinberggroup.com
Questions?
12. 12
About your speaker…
Michael A. Swit, Esq., is a Vice President at THE WEINBERG GROUP, where he develops and ensures the
execution of a broad array of regulatory and other services to clients, both directly and through outside counsel. His
expertise includes product development strategies, compliance and enforcement initiatives, recalls and crisis
management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical
research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food and
dietary supplement industries.
Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His multi-faceted experience
includes serving for three and a half years as corporate vice president, general counsel and secretary of Par
Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial
perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as CEO of
FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the
FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel in the
FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug
Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego. He first practiced
FDA regulatory law with the D.C. office of Burditt & Radzius.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial
activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and
editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the
Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored
by such organizations as RAPS, FDLI, and DIA. A magna cum laude graduate of Bowdoin College, he received his
law degree from Emory University Law School and is a member of the California, D.C. and Virginia bars.
13. 13
For twenty –five years, leading companies have
depended on THE WEINBERG GROUP when their
products are at risk. Our technical, scientific and
regulatory experts deliver the crucial results that get
products to market and keep them there.
Washington ♦ New York ♦ San Francisco
Brussels ♦ Edinburgh