Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser
Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
A changing competitive landscape: the role of the ITC in the biosimilars space
Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more
The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more