2014

"Compliance Challenges within Medical Affairs" by Thomas Sullivan, Policy and Medicine blog (June 2014)

FDA response (June 2014) to "scientific exchange" Citizen's petition (7/2011) and follow-on petition (9/2013) submitted by Ropes & Gray and Sidley Austin LLP on behalf of seven product manufacturers

"How to Determine a Pharmaceutical Product's 'Country of Origin'" Public Contract Law Journal (May 2014)

"Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012" JAMA (January 2014)

2013

"The Differences with Pharmaceutical and Device Promotion Standards" by Thomas Sullivan, Policy and Medicine blog (November 2013)

"Industry Standards for Linking Disease Awareness Websites to Product Promotion" by Dale Cooke Regulatory Focus (October 2013) 

Citizen petition from MIWG (follow-on to the 7/2011 petition) regarding dissemination of "off-label" information (September 2013)

"FDA Building a Prescription Drug and Marketing Database" Policy and Medicine  (June 2013) 

'[Labeling p]otential of patient-reported outcomes as nonprimary endpoints in clinical trials" Health and Quality Life Outcomes (May 2013)

"Social Media and Prescription Drug Promotion: A Survey of Seven Companies’ Practices" Social Media Law & Policy Report (April 2013) 

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

"An Erosion of Power: The New Paradigm of FDA Drug Enforcement Actions" Pharmaceutical Law & Industry Report (March 2013) 

"Drug Promotion in the Post-Caronia WorldFDLI Update (March 2013) 

"Former Biotech CEO Loses Free Speech Appeal" (Pharmalot, March 2013)

Webinar on the Caronia Decision.  Hyman, Phelps & McNamara (February 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 companiesBMC Health Serv Res. 2013 Jan 22;13:27

"Corporate Integrity Agreements: What They Say About Publications, Publication Planning, Transparency, and ICMJEDrug Information Journal, January 2013 vol. 47 no. 1 50-56

 

Earlier

"Pharma Challenges: Adverse Event Reporting and Social MediaBloomberg Law (2012)   

FDA actions against health economic promotions, 2002-2011” Value Health 2012 Sep;15(6):948-53

"From MSL to CSL: The evolving role of the medical science liaison"  Compliance Today, March 2012

Communication of CER Findings” Bob Temple presentation re: FDAMA 114 at the National Pharmaceutical Council conference, Asymmetry in the Ability to Communicate CER Findings: Ethics and Issues for Informed Decision Making (February 2012)

“Substantial Evidence: When Is a Single Trial Sufficient for Approval and Promotion?” Drug Information Journal, Vol. 45, pp. 253-263, 2011

 "The Food and Drug Administration’s Evolving Regulation of Press Releases: Limits and ChallengesFDLI Journal 2006