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

  

Ensuring Compliance with FDA Requirements for 

Advertising  & Promotion of Drugs & Medical Devices 

Course Instructor 

Two-Day Course. ComplianceOnline. 

February 7 & 8, 2019 ♦ San Francisco

May 29 & 30, 2019 ♦ Boston

August 8 & 9, 2019 ♦ San Diego

November 14 & 15, 2019 ♦ Minneapolis

For More Info, click here


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


FDA Enforcement:  Understanding the 

Consequences of Non-Compliance

Presentation to

MAGI Clinical Research Conference 2019 East

May 5 - 8, 2019 ♦ Boston

For more info, click here


Scientific Exchange:  New Perspectives

Presentation to:

Drug Information Association Annual Conference

June 23 - 27, 2019 ♦ San Diego

For more info, click here


RECENT TALKS & PRESENTATIONS

 

Ensuring Compliance with FDA Requirements for 

Advertising  & Promotion of Drugs & Medical Devices 

Course Instructor 

Two-Day Course. ComplianceOnline.   

November 1-2, 2018.  Boston, MA.


Ensuring  FDA Success for Biomedical Companies -- 

Key Lessons for Start-Ups

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. 


FDA Clinical Research Inspections:  

Handling the Administrative and Legal Consequences -- 

Understanding How Ugly It Can Get 

Presentation to

Master Class:  Regulatory Compliance

MAGI Clinical Research Conference

October 21, 2018.  San Diego.


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.

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