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
On July 15, 2022, the Food and Drug Administration (FDA) issued its final guidance on developing the content and format of patient Instructions for Use (IFU) for human prescription drug and biological products, as well as...more
In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft...more
On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the guidance,...more
FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On...more
U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons....more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
USJMF and Wilson Sonsini Host Successful Japan Trade Mission and Roadshow for U.S. Medtech Companies - On November 5-11, 2019, U.S.-Japan Medtech Frontiers (USJMF) and Wilson Sonsini led a group of representatives from 22...more
On May 10, 2019, the Food and Drug Administration issued highly anticipated final guidance that gives drug-makers more clarity on how to demonstrate that a proposed biosimilar product meets the statutory interchangeability...more
On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable...more
On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product,...more
FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products. This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance)....more
Despite nearly universal opposition from both biosimilar makers and innovator companies, FDA has issued final guidance adopting its controversial August 2015 proposal for naming biologics. Under the guidance adopted by FDA,...more