Newest Developments

Publications

Author, “How Data Integrity Issues Sunk a $4.3 Billion Drug Company Acquisition – Lessons Not Just for Quality Professionals, But Also Their Top Management. Legal Letter from America. GMP Review,.  October  2018. Volume 17, No. 3, pp. 18-20.  


Pharmaceutical Compliance and Enforcement Answer Book, Practicing Law Institute (PLI), June 2018. 

          Chapter 4 -- FDA Regulations and Enforcement Actions Relative to Oversight of Advertising and 

          Promotion 

          Chapter 15 -- Collateral Consequences of Violating the Federal Food, Drug, and Cosmetic Act,
                         
For ordering information, click here 

Events -- Past and Future

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.

[click here to link to slide decks]


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.

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