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.
“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
“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