Presentation to the Arrowhead Drug Delivery Summit, May 2009, in San Francisco, focusing on:
The FDA World –how is it changing?
Combination Product Regulation –where drug delivery intersects with agency purview
How FDA approaches combination products
Real time examples
Getting prepared --How to focus on FDA regulatory issues in drug delivery
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
Overcoming Regulatory, Clinical and Quality Challenges in Developing Combinat...Michael Swit
Webinar presented on May 19, 2011, sponsored by The Weinberg Group, focusing 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
The FDA Inter-Centers Agreement: Combination Products and the Changed BLA Rev...Michael Swit
This 2003 presentation includes a perspective on the history of FDA regulation of combination products, with a particular emphasis on the changes implemented by MDUFMA in 2002.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
November 10, 2015 webinar sponsored by Compliance2Go reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses.
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
Overcoming Regulatory, Clinical and Quality Challenges in Developing Combinat...Michael Swit
Webinar presented on May 19, 2011, sponsored by The Weinberg Group, focusing 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
The FDA Inter-Centers Agreement: Combination Products and the Changed BLA Rev...Michael Swit
This 2003 presentation includes a perspective on the history of FDA regulation of combination products, with a particular emphasis on the changes implemented by MDUFMA in 2002.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
November 10, 2015 webinar sponsored by Compliance2Go reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses.
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
January 29, 2015 webinar sponsored by Compliance2Go, with a focus on:n the various approaches to drug and device approval/marketing that differ from standard method, including:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
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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
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
Navigating the US FDA for Combination ProductsEMMAIntl
Our RA Manager Song Seto guides you through the FDAs pathway to get your combination product to the US market. Learn more about the combo products pre-market submission reviews and the other mechanism devised by the FDA and things that you should include in your pre-market submission.
This presentation gives an overview of the Drug Master File, a document submitted by the company or pharmaceutical industry to the regulatory authorities. It indicates that the company's product meets the desired quality standards. A brief introduction followed by types of DMF, its reviewing procedure and applications may give you a better understanding about Drug Master File.
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
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.
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
January 29, 2015 webinar sponsored by Compliance2Go, with a focus on:n the various approaches to drug and device approval/marketing that differ from standard method, including:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
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
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
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
Navigating the US FDA for Combination ProductsEMMAIntl
Our RA Manager Song Seto guides you through the FDAs pathway to get your combination product to the US market. Learn more about the combo products pre-market submission reviews and the other mechanism devised by the FDA and things that you should include in your pre-market submission.
This presentation gives an overview of the Drug Master File, a document submitted by the company or pharmaceutical industry to the regulatory authorities. It indicates that the company's product meets the desired quality standards. A brief introduction followed by types of DMF, its reviewing procedure and applications may give you a better understanding about Drug Master File.
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
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.
COMBINATION PRODUCTS – Perspectives on FDA RegulationMichael Swit
Overview of FDA regulation of combination products -- those featuring a drug and a device, a device and a biologic, or a biologic and a drug. Reviews key issues such as Primary Mode of Action, Requests for Designation, and how to handle GMPs and Adverse Event Reporting for combination products.
FDA Legal & Regulatory Considerations for Biomedical StartupsMichael Swit
Presentation to the Tech Coast Angels on key legal and regulatory considerations for biomedical (drug and device) start-up companies, given on March 7, 2003.
FDA Regulatory Considerations for Life Sciences CompaniesMichael Swit
April 2008 presentation to Swedish-American Chamber of Commerce Entrepreneurial Days on FDA issues for product development, including focus on:
Planning, approval process, barriers to entry
FDA classify Medical Devices and how to report device problems A Systematic R...Pubrica
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FDA classify Medical Devices and how to report device problems A Systematic R...Pubrica
The typical time it takes to get a device to market is 3 to 7 years, compared to 12 years for pharmaceuticals. However, there are concerns that the Food and Drug Administration's Systematic Review Writing methods may not be adequate to satisfy the required guarantees of safety and efficacy.
Learn More : https://pubrica.com/services/research-services/systematic-review/
Reference: https://bit.ly/3xNHUsC
Why Pubrica:
When you order our services, we promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Bio statistical experts | High-quality Subject Matter Experts.
Contact us:
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-1618186353
Federal Regulatory Issues Us Food And Drug Administration Medical Device Amen...Jacobe2008
Authors:
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This document contains the mostly asked questions for the job interviews of drug regulatory affairs which will help the candidate ace the interview with ease
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Drug Delivery -- Perspectives on the FDA Regulatory Environment
1. Arrowhead Drug Delivery Summit
San Francisco
May 14, 2009
Michael A. Swit, Esq.
Vice President
Drug Delivery -- Perspectives on
the FDA Regulatory Environment
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
should not be relied upon solely on its own to
support any conclusion of law or fact.
3. What We Will Cover
The FDA World – how is it changing?
Combination Product Regulation – where drug delivery
intersects with agency purview
How FDA approaches combination products
Real time examples
Getting prepared -- How to focus on FDA regulatory
issues in drug delivery
5. “Global” Environment
Obama Administration – what does it foretell
Universal health care …?
Comparative effectiveness – keep an eye on this
Increased enforcement/compliance activity – get your house
in order – beware the “Fear of Wiley”
FDA Issues
New commissioner – Margaret Hamburg nominated
Cleared yesterday by Senate H.E.L.P. Committee; full confirmation
not set yet
any biases/predilections?
Reported she is interested in food safety
Deputy Commissioner – Josh Sharfstein – ex-Waxman staffer
6. FDA Environment -- Drugs
Safety – mantra – life changed on September 30, 2004
Result –
FDA is very risk averse
“Show me”
Don’t get called up in front of Congress for not approving a drug
FDAAA -- increased emphasis on risk/benefit analyses and
risk management
Can mandate a REMS – Risk Evaluation and Mitigation Strategy
Can mandate post-approval studies
Industry – must improve early detection of drug event signals
7. FDA Environment – Devices
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”
OIVD – Gutman left – where to?
Prolonged Congressional inquiry -- very disruptive 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.
Sharfstein just ordered CDRH to re-examine clearance of knee
surgery device allegedly secured in part due to Congressional pressure
8. Device Approval/Marketing Issues
510k Process – in spotlight
GAO report – required by FDAAA
Includes a focus on FDA’s failure to require PMAs or reclassify a
number of pre-’76 devices as required by the 1990 Safe Medical
Devices Act
If put in Class III, PMA’s will be needed
None were IVDs
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%
Partial result – call for data on pre-76 devices – April 9
Lingering issue – “substantial equivalence drift”
9. 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
11. What Is a Combination Product?
As defined in 21 CFR § 3.2(e), the term combination product includes:
(1) A product comprised of two or more regulated components, i.e., drug/device,
biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or
otherwise combined or mixed and produced as a single entity;
(2) Two or more separate products packaged together in a single package or as a unit and
comprised of drug and device products, device and biological products, or biological and drug
products;
(3) A drug, device, or biological product packaged separately that according to its
investigational plan or proposed labeling is intended for use only with an approved
individually specified drug, device, or biological product where both are required to
achieve the intended use, indication, or effect and where upon approval of the proposed
product the labeling of the approved product would need to be changed, e.g., to reflect a
change in intended use, dosage form, strength, route of administration, or significant change in
dose; or
(4) Any investigational drug, device, or biological product packaged separately that according
to its proposed labeling is for use only with another individually specified investigational
drug, device, or biological product where both are required to achieve the intended use,
indication, or effect.
13. A Brief History
Office of Combination Products (“OCP”)
Created by Medical Device User Fee and
Modernization Act (MDUFMA)
Office established on December 24, 2002
OCP given broad oversight responsibilities covering
the regulatory life cycle of combination products.
Coordinate reviews among FDA Centers
Ensure consistency among similar reviews
14. Section 503(g) of the Act
FDA is required to assign a combination product to a lead Center
based on its "primary mode of action“ -- PMOA
PMOA was not defined in the statute or regulations
For some products, PMOA is difficult to identify
Early in development (just don't know)
Products that have two (or more) completely different modes
of action, neither of which is subordinate to other
Nanotech – additional challenges
15. PMOA -- Determining Which Center Leads
PMOA = Primary Mode of Action; not defined in statute, but in
regulations
Final Rule – 8/25/2005; 70 Fed. Reg. 49848
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-16527.pdf
Mode of Action: the means by which a product achieves an intended
therapeutic effect or action.
21 CFR 3.2(k)
Three types of modes of action: biological product, device, drug
Combination products typically have more than one identifiable mode
of action
16. PMOA …
Primary mode of action is the single mode of action of a
combination product that provides the most important
therapeutic action of the combination product. The most
important therapeutic action is the mode of action expected
to make the greatest contribution to the overall intended
therapeutic effects of the combination product.
Source: 21 CFR 3.2(m)
17. The PMOA Decision Tree
If unable to determine most important therapeutic
action with reasonable certainty, consider:
Consistency: is there an agency component that regulates other
combination products presenting similar questions of S & E
with regard to the combination product as a whole?
Safety and Effectiveness: which agency component has the
most expertise related to most significant S&E questions
presented by combination product?
18. Not Sure – Requests for Designations (RFDs)
Voluntary Formal Process under 21 CFR Part 3
Seeks to determine:
Classification
Assignment
Clarification of Regulatory Pathway
If don’t file, FDA may stay review clock while a determination is made
When:
Before any application for premarket review
As soon as enough info exists for FDA to make a decision
19. RFD’s …
Key sections to focus on:
What is your product?
Why would your product be used?
How does your product work?
What is your product’s most important therapeutic action?
What is the basis for your PMOA analysis?
How do you think your product should be assigned?
Why? Use assignment algorithm if appropriate.
20. RFD’s …
OCP reviews RFD’s for completeness
If complete, OCP sends acknowledgement letter to sponsor, and copy
of RFD’s to three Center Liaisons
Center recommendations due to OCP in 21 days
Consultation among OCP, Centers and Office of Chief Counsel
Decision reached, response letter prepared, necessary clearances
obtained
Decision must issue within 60 days; if not YOUR recommendation
wins!!
21. RFD’s …
Request for Reconsideration
Submit within 15 days
Less than 5 page submission, no new information
FDA response within 15 days
FDA has been known to change a decision upon reconsideration
Effect of RFD Letter – designated FDA Center can only be changed
without your consent to protect the public health or another
compelling reason.
Source: 21 CFR 3.9(b)
22. How Many Applications?
Concept Paper on Marketing Applications for Combination Products
http://www.fda.gov/oc/combination/singlesepconpaper.pdf
Basics:
PMOA does not ensure application status; but lead Center
Single application usually is sufficient
Exceptions
One component is already approved, but labeling will need to be changed
Biologics – legally can have separate apps. for components
When the components are “separate and complex” – e.g., a device in combination
with a new molecular entity drug/biologic
Where needed to “apply mechanisms to ensure appropriate regulation or unique
regulatory requirements” not available under one app.
Example: gene therapy
23. How Many Applications?...
You Might Want Two – perhaps:
To qualify for Waxman-Hatch Exclusivity
Orphan Drug Status
To protect proprietary data if 2 firms are involved
Complex decision tree suggested in concept paper on how
these are handled
Examples
Single application – pre-loaded syringes, transdermal patches
Two or more – laser activated drugs, iontophoresis
24. Drug Delivery Successes at FDA
Neupro Patch – Early Parkinson’s Disease – rotigotine
transdermal
InFuse Bone Graft – for filling in missing tooth bone
Methlyphenidate Patch – ADHD in children
Emsam Patch – Selegiline for depression
Exubera – inhaled insulin –
Not a market success
Integrated glucose monitor and insulin delivery system
26. Be Prepared
“Validate” plans early
Take advantage of FDA meeting opportunities
Pre-IND, EOP2, Pre-NDA/BLA filing
Pre-IDE
VC’s – will expect you to know what you are doing
But, don’t roll over and accept what FDA says without
questions
Don’t Assume Europe and U.S. Think Alike
BioSimilars – EU is ahead of U.S.
Scientific Advice process
27. Be Prepared …
When does drug delivery become the PMOA?
Historically, with delivery systems, the focus on the
therapeutic moiety
But, could the improved delivery be the PMOA?
Try to be a PMA – stent precedent allows you where the drug
component does not need an NDA
Know Your Partners
Audit them
Their problems are yours – e.g., Cialis and Lilly
29. Call, e-mail, fax or write:
Michael A. Swit, Esq.
Vice President
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?
30. 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 drug and biologics clients seeking to market products in
the United States. His expertise includes FDA development strategies, compliance and enforcement initiatives, recalls
and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and
clinical research efforts.
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.