Search

All OPDP/DDMAC enforcement letters (since 1997) on the FDA website

Google search of FDA website for OPDP/DDMAC letters with the word "misleading" — replace "misleading" in the search box to search other terms

Summaries

CY 2013 OPDP Enforcement Summaries

Covington & Burlington E-Alerts (monthly and end-of-year summaries of FDA promotional letters, including OPDP) 

OPDP holds semi-annual webinars on recent enforcement letters (usually announced on its main webpage).

Analysis

"Warning and Untitled Letters By Therapeutic Category – Oncology" by Mark Senak, Eye on FDA (June 2014)

"Use of Testimonials and Endorsements in Prescription Drug Advertisements" by Mary Sullivan, Regulatory Focus (September 2013)

Eye on FDA's analysis of promotion of investigational compounds (August 2013).  Part 1 and Part 2.

"Patient Testimonial Videos: FDA Actions on Risk Information Presentation" by Dale Cooke, Regulatory Focus (July 2013) 

"Compliant Promotion in an On-Demand World" Presentation by Dale Cooke (June 2013)

"FDA Regulation of Pharma Communications in a Digital Era" White paper by Mark Senak, Eye on FDA (April 2013). 

"Increased FDA Scrutiny Of Pre-Approval Communications Continued in 2012" Sidley Austin Update (February 2013)  

"Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies" BMC Health Serv Res. 2013 Jan 22;13:27

"Review of DDMAC / OPDP Warning and Untitled Letters By Therapeutic Category [2009-2011]" Sidley Austin Update (November 2011)