Overview
Given his particular experiences, Brian Malkin frequently is asked to write on numerous FDA- and intellectual-property-law issues, including clinical trials and new product development for complex and challenging products, such as biotechnology products, orphan drugs, generic drugs, 505(b)(2) new drug applications, patent-term restoration under the Hatch-Waxman Act, biosimilar products, tobacco products, patent-term adjustment, risk management and due diligence. View Brian’s pre-McDermott articles below.
- “Companies Marketing CBD Products Be Warned: FDA Is Watching,” Law360, December 5, 2017
- “New FDA Rules Put Onus On Doctors To Curb Opioid Abuse,” Law360, March 28, 2016
- “Biosimilars patent litigation in the EU and the US: a comparative strategic overview,” Generics and Biosimilars Initiative (GaBI) Journal, Volume 4, Issue 3, 2015
- “Food, Drug, Cosmetic Section Profile: Section helps food and drug law attorneys explore FDA guidance, legislation with a New York ” State Bar News, New York State Bar Association, November/December 2015
- “Biosimilars patent litigation in the EU and the US: a comparative strategic overview,” GaBI Journal, August 19, 2015
- “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
- “Will the FDA Provide More Guidance or Manage the Process to Share Risk Evaluation and Mitigation Strategies (REMS)?,” Financier Worldwide, October 2013
- 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 Special Report), Aspatore/Thompson Reuters, September 1, 2013
- Co-author, The Drug/Biologics Approval Process: An FDLI Primer, Food and Drug Law Institute Update Magazine, January 2013
- “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
- “The Letter of the Law: How FDA Regulation Will Impact Your Business,” Tobacco Reporter, August 1, 2009