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FDA Life News and Trends Impacting the FDA and Life Science Industry

Articles

Kathleen Dooley

Author, “A Stern Warning To CFPB On Supervising Practices,” Law 360, April 24, 2014

Co-author, “Pharmaceutical Product Diversion: An Ounce of Prevention is a Cure for Compliance,” Pharmaceutical Compliance Monitor, May 9, 2012

Co-author, “Analysis of Pharmaceutical Product Diversion and the Gray Market: Cheaper Drugs but as What Cost,” Health Care Law Monthly, September 2010

 

Brian Malkin

Author, “Biosimilars patent litigation in the EU and the US: a comparative strategic overview,” Generics and Biosimilars Initiative (GaBI) Journal, August 2015.

Author, “The FDA’s Ever-Broadening Regulatory Oversight Creates Need for Increased (and More) User Fees: How Will This Affect Enforcement, the Increasing Need for Sponsor Self-Regulation, and the FDA’s Regulatory Priorities?,” Recent Developments in Food and Drug Law (2015 Edition), Aspatore/Thompson Reuters, December 2014

Author, “Will the FDA Provide More Guidance or Manage the Process to Share Risk Evaluation and Mitigation Strategies (REMS)?,” Financier Worldwide, October 2013

Author, “Free Speech and Off-Label Drug Promotion: Should Recent Cases Change Your Business Practices?: Navigating Recent Off-Label Promotion Developments, Understanding Government Relations and the Potential Impact of Noteworthy Cases,” Aspatore/Thompson Reuters Special Report, September 1, 2013

Co-author, “The Drug/Biologics Approval Process: An FDLI Primer,” Food and Drug Law Institute Update Magazine, January 2013

Author, “Challenges to the Development of a Biosimilars Industry in the United States,” Aspatore/Thompson Reuters Recent Developments in Food and Drug Law (2013 Edition), December 3, 2012

Co-author, “Should FDA Understake More Than a “Ministerial” Role with Respect to Patent Information?,” Food and Drug Law Institute Policy Forum, February 23, 2011

Co-author, “Disentangling Biobetters under the Biologics Price Competition and Innovation Act of 2009,” Food and Drug Law Institute Update Magazine, February 1, 2011

Co-author, “Biosimilars Are a Reality: Key Feautres of the Biologics Price Competition and Innovation Act,” Food and Drug Law Institute Update Magazine, June 1, 2010

Author, “The Letter of the Law: How FDA Regulation Will Impact Your Business,” Tobacco Reporter, August 1, 2009