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


Co-Chair

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

June 25-26, 2018.  San Diego, CA

For more info, click here


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

For more info, click here


Transitioning to Non-Orphan Indications for Orphan Drugs.

Moderator, Panel Discussion, at 

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

June 26, 2018.  San Diego, CA

For more info, click here

  

Regulation of Drug Manufacturing.

Presentation to

 Food & Drug Law Institute.

  Introduction to US Drug Law and Regulation. 

July 24-25, 2018. San Francisco.

For more info, click here


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.

For more info, click here


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

Two-Day Course. ComplianceOnline.  

July 26-27, 2018.  Chicago, IL.

For more info, click here


Critical Legal Issues Facing GMP Compliance.  

Presentation to

23rd Annual GMP By The Sea Conference.  

August 27-29, 2018.  Cambridge, MD.
For more info, click here

RECENT TALKS & PRESENTATIONS


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.


FDA Inspections:  Handling the Consequences -- 

Understanding How Ugly It Can Get. 

Presentation to 

MAGI's Clinical Research Conference

May 22, 2018.  Arlington, VA. 


What's In a Name?  FDA and 

Non-Proprietary Names for Biosimilars.  

Presentation to 

11th Biosimilars & Follow-On Biologics 2018 Americas.  

Paradigm Global Events.

April 20, 2018.  McLean, Virginia.


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

Two-Day Course. ComplianceOnline.  

March 22-23, 2018.  San Francisco, CA.  


Slides:
Part 1:  Basics

     Part 2:  Direct-to-Consumer Advertising

Part 3:  Scientific Dissemination  

     Part 4:  FDA Enforcement

Part 5:  Social Media & Internet  

Part 6:   First Amendment, Off-Label & False Claims; Guidance on Medical Product Communications Consistent with Labeling
Part 7:  FTC Regulation

     Part 8:  Handling at Company Level


The Application Integrity Policy (AIP):  A Little History.
Webinar Presentation

Food & Drug Law Institute (FDLI).

March 13, 2018


EU MDR & IVDR Implications for Manufacturers & Suppliers.
Moderator, Panel Discussion, at 

MD&M West, 

February 7, 2018, Anaheim, CA.  

[no slides; moderator]

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