November 10, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
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
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.
Doctors’ Views of Direct-to-Consumer Drug AdvertisingCMI_Compas
CMI/Compas Study on Doctors’ Views of Direct-to-Consumer Drug Advertising, April 2013, In Preparation for the FDA Survey of Clinicians on Direct-to-Consumer Drug Advertising
Medical Device Advertising Law & RegulationMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference in San Francisco, CA, focusing on:
* Basics of the Law
* Regulation of Promotion/Advertising
* Off Label Promotion & the First Amendment
* Other Legal Concerns Impacting Advertising
* The AdvaMed Code
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
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.
Doctors’ Views of Direct-to-Consumer Drug AdvertisingCMI_Compas
CMI/Compas Study on Doctors’ Views of Direct-to-Consumer Drug Advertising, April 2013, In Preparation for the FDA Survey of Clinicians on Direct-to-Consumer Drug Advertising
Medical Device Advertising Law & RegulationMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference in San Francisco, CA, focusing on:
* Basics of the Law
* Regulation of Promotion/Advertising
* Off Label Promotion & the First Amendment
* Other Legal Concerns Impacting Advertising
* The AdvaMed Code
The term “cosmeceutical” has become popular in recent years to describe a cosmetic product that claims medicinal benefits. While those in the cosmetic industry use the term to advertise the ingredients and benefits of their products, the FDA does not legally recognize the term...
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,
The Application Integrity Policy (AIP): A Little History.Michael Swit
Presentation to the Food & Drug Law Institute Annual Enforcement, Litigation & Compliance Conference for the Drug, Device, Food, and Tobacco Industries. December 5, 2017. Washington, D.C.
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
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
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 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
FDA Regulation of Promotion & Advertising Part 6B: First Amendment, Off-Label...Michael Swit
November 10, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
FDA Enforcement – Trends, Powers and Penalties Or “Why Crime Does Not Pay”Michael Swit
June 12, 2009 presentation to the Southern California Biomedical Council on FDA enforcement, with a focus on:
FDA Regulatory/Enforcement Authority --
Understanding
FDA Enforcement Trends
Drugs
Devices
Clinical Trials
Collateral Consequences of FDA Violations
FDA Regulation of Promotion & Advertising-- Part 6A: Draft Guidance on Medica...Michael Swit
November 9, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
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.
Why Compliance is a Tough Pill to Swallow – NutraceuticalsAffiliate Summit
This presentation is from Affiliate Summit West 2014 (January 12-14, 2014 in Las Vegas, NV). Session description: Discussion of strategies for manufacturers and marketers of nutraceuticals to avoid both FTC and FDA scrutiny, as well as recent FDA warning letters and trending enforcement tactics.
Combination Products, Orphan Drugs and OTC DrugsMichael Swit
Presentation to the 2016 Regulatory Affairs Certification (RAC) Test Review Course sponsored by the San Diego Regulatory Affairs Network (SDRAN) in July 2017, with a focus on:
A Brief History of Combination Product Regulation
Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
The Request for Designation (RFD) Process
GMPs
Post-Market Safety Reporting
How Many Applications to File?
User Fees
Drug Safety – Perspectives on Industry’s Duties in the Post-Vioxx AgeMichael Swit
Presentation to the Orange County Regulatory Affairs (OCRA) Discussion Group/FDA Joint Annual Educational Conference. June 2009., focusing on:
FDA’s Enhanced Drug Safety Powers
FDAAA and REMS
REMs in Action
What Should Industry Be Doing?
Understanding potential liability
“Avoiding” Liability
What Else Might FDA Do to Assure Drug Safety?
or What Should Industry Be Prepared For?
A Side Note on Products Liability and Drug Safety in
the Wake of Wyeth v. Levine
The term “cosmeceutical” has become popular in recent years to describe a cosmetic product that claims medicinal benefits. While those in the cosmetic industry use the term to advertise the ingredients and benefits of their products, the FDA does not legally recognize the term...
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,
The Application Integrity Policy (AIP): A Little History.Michael Swit
Presentation to the Food & Drug Law Institute Annual Enforcement, Litigation & Compliance Conference for the Drug, Device, Food, and Tobacco Industries. December 5, 2017. Washington, D.C.
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
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
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 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
FDA Regulation of Promotion & Advertising Part 6B: First Amendment, Off-Label...Michael Swit
November 10, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
FDA Enforcement – Trends, Powers and Penalties Or “Why Crime Does Not Pay”Michael Swit
June 12, 2009 presentation to the Southern California Biomedical Council on FDA enforcement, with a focus on:
FDA Regulatory/Enforcement Authority --
Understanding
FDA Enforcement Trends
Drugs
Devices
Clinical Trials
Collateral Consequences of FDA Violations
FDA Regulation of Promotion & Advertising-- Part 6A: Draft Guidance on Medica...Michael Swit
November 9, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.
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.
Why Compliance is a Tough Pill to Swallow – NutraceuticalsAffiliate Summit
This presentation is from Affiliate Summit West 2014 (January 12-14, 2014 in Las Vegas, NV). Session description: Discussion of strategies for manufacturers and marketers of nutraceuticals to avoid both FTC and FDA scrutiny, as well as recent FDA warning letters and trending enforcement tactics.
Combination Products, Orphan Drugs and OTC DrugsMichael Swit
Presentation to the 2016 Regulatory Affairs Certification (RAC) Test Review Course sponsored by the San Diego Regulatory Affairs Network (SDRAN) in July 2017, with a focus on:
A Brief History of Combination Product Regulation
Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
The Request for Designation (RFD) Process
GMPs
Post-Market Safety Reporting
How Many Applications to File?
User Fees
Drug Safety – Perspectives on Industry’s Duties in the Post-Vioxx AgeMichael Swit
Presentation to the Orange County Regulatory Affairs (OCRA) Discussion Group/FDA Joint Annual Educational Conference. June 2009., focusing on:
FDA’s Enhanced Drug Safety Powers
FDAAA and REMS
REMs in Action
What Should Industry Be Doing?
Understanding potential liability
“Avoiding” Liability
What Else Might FDA Do to Assure Drug Safety?
or What Should Industry Be Prepared For?
A Side Note on Products Liability and Drug Safety in
the Wake of Wyeth v. Levine
Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governi...Michael Swit
Webinar sponsored by The Weinberg Group on Orphan Drugs, covering these topics:
The Basics of the Orphan Drug Act
Benefits of Orphan Drug status
Exclusivity
Protocol assistance, tax credits, and research grants
When is an indication is “rare”?
Orphan Drug Designation Requests – ensuring yours
robust and persuasive
Approval criteria for orphan products – how they
compare to non-orphan products
Challenges in the Orphan Drug Process
Combination Products, Orphan Drugs and OTC DrugsMichael Swit
Presentation to the 2017 Regulatory Affairs Certification (RAC) Test Review Course sponsored by the San Diego Regulatory Affairs Network (SDRAN) in July 2017, with a focus on:
A Brief History of Combination Product Regulation
Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
The Request for Designation (RFD) Process
GMPs
Post-Market Safety Reporting
How Many Applications to File?
User Fees
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.
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.
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.
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
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.
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.
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.
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.
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.
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
How to Obtain Permanent Residency in the NetherlandsBridgeWest.eu
You can rely on our assistance if you are ready to apply for permanent residency. Find out more at: https://immigration-netherlands.com/obtain-a-permanent-residence-permit-in-the-netherlands/.
A "File Trademark" is a legal term referring to the registration of a unique symbol, logo, or name used to identify and distinguish products or services. This process provides legal protection, granting exclusive rights to the trademark owner, and helps prevent unauthorized use by competitors.
Visit Now: https://www.tumblr.com/trademark-quick/751620857551634432/ensure-legal-protection-file-your-trademark-with?source=share
In 2020, the Ministry of Home Affairs established a committee led by Prof. (Dr.) Ranbir Singh, former Vice Chancellor of National Law University (NLU), Delhi. This committee was tasked with reviewing the three codes of criminal law. The primary objective of the committee was to propose comprehensive reforms to the country’s criminal laws in a manner that is both principled and effective.
The committee’s focus was on ensuring the safety and security of individuals, communities, and the nation as a whole. Throughout its deliberations, the committee aimed to uphold constitutional values such as justice, dignity, and the intrinsic value of each individual. Their goal was to recommend amendments to the criminal laws that align with these values and priorities.
Subsequently, in February, the committee successfully submitted its recommendations regarding amendments to the criminal law. These recommendations are intended to serve as a foundation for enhancing the current legal framework, promoting safety and security, and upholding the constitutional principles of justice, dignity, and the inherent worth of every individual.
Military Commissions details LtCol Thomas Jasper as Detailed Defense CounselThomas (Tom) Jasper
Military Commissions Trial Judiciary, Guantanamo Bay, Cuba. Notice of the Chief Defense Counsel's detailing of LtCol Thomas F. Jasper, Jr. USMC, as Detailed Defense Counsel for Abd Al Hadi Al-Iraqi on 6 August 2014 in the case of United States v. Hadi al Iraqi (10026)