Newest Developments

Just Published ...

Proud to have contributed 2 chapters to the Pharmaceutical Compliance and Enforcement Answer Book, published in June 2018, by the Practicing Law Institute (PLI).  


To view the Table of Contents, which includes my Chapter 4 on FDA Regulations and Enforcement Actions Relative to Oversight of Advertising and Promotion and Chapter 15 on the Collateral Consequences of Violating the Federal Food, Drug, and Cosmetic Act,
click here 


For ordering information, click here

Events

FUTURE TALKS & PRESENTATIONS

 

Master Class:  Regulatory Compliance

Presentation to

MAGI Clinical Research Conference

October 21 to 24, 2018  ♦ San Diego.

For more info, click here


Regulatory,  Reimbursement, and Market Entry

Panelist

Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the  Small Business Development Center @ UCI Applied Innovation (SBDC) 

October 25, 2018 ♦ Irvine, California

For more info, click here


Ensuring Compliance with FDA Requirements for Advertising
& Promotion of Drugs & Medical Devices

Course Instructor 

Two-Day Course. ComplianceOnline.  
November 1-2  ♦  Boston, MA.

For more info, click here


Regulatory, Compliance, and Policy Developments:  

Are You Up-to-Date?

Panelist at

"Emerging Trends in Medical Devices: New Regulations, New Guidance, New Challenges, and New Opportunities" 

A Virtual Conference

Sponsored by FDAnews.com

December 6, 2018  ♦ 10 am to 5 pm ET

More info to be added.


A Practical Look at Legal & Regulatory Issues in 

Promoting Diagnostics and Related Products 

Presentation to 

DIA Advertising & Promotion Regulatory Affairs Conference

February 28, 2019 - March 1, 2019  ♦ Bethesda, Maryland.

For more info, click here



RECENT TALKS & PRESENTATIONS

 

Basics of FDA Regulation of  Device & IVD Advertising 

and

FDA Regulation of Advertising  of Diagnostics, RUO Products, 

and  Laboratory Developed Tests 

Presentations to 

FDLI Advertising & Promotion Conference

October 16, 2018.  Washington, D.C.


Orphan Drugs & Rare Diseases 2018 Americas East Coast

Co-Chair

September 24-26.  Boston, Massachusetts.

 

Critical Legal Issues Facing GMP Compliance.  

Presentation to

23rd Annual GMP By The Sea Conference.  

August 27, 2018.  Cambridge, MD.

 

Combination Products, OTC Drugs, and Orphan Drugs. 

Presentation to

Regulatory Affairs Certification (RAC) Review Course. San Diego Regulatory Affairs Network (SDRAN). 

July 26, 2018. Webinar.


FDA Regulation of Drug Manufacturing.

Presentation to

Food & Drug Law Institute.

 Introduction to US Drug Law and Regulation. 

July 25, 2018. San Francisco.


Scientific Exchange:  New Interpretations??

Webinar Presentation to:

Drug Information Association (DIA)  AdPromo Working Group

July 25, 2018.


Latest Developments in and the Future of the 

Regulatory Landscape for Approving Treatments 

for Orphan and Rare Diseases.

Presentation to 

Orphan Drugs & Rare Diseases -- 2018 Americas West Coast.

June 25, 2018.  San Diego, CA


Transitioning to Non-Orphan Indications for Orphan Drugs.

Moderator, Panel Discussion

[no slides] 

Orphan Drugs & Rare Diseases -- 2018 Americas West Coast.

June 26, 2018.  San Diego, CA


Generic Drugs and Biosimilars 

Presentation to

Regulatory Affairs Certification (RAC) Review Course. San Diego Regulatory Affairs Network (SDRAN). 

June 14, 2018. Webinar.


Is a Quality Agreement Required for All Suppliers? 

Panel Discussion

[no slides]

4th Annual ComplianceOnline Medical Device Summit

June 7, 2018.  San Francisco.

 

Recent FDA Developments in Digital Health & 

Clinical Decision Support Software

Presentation to 

4th Annual ComplianceOnline Medical Device Summit

June 7, 2018.  San Francisco.

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