Topic
FDA Approval
200 published works
Biosimilars Law Bulletin
Coherus Scores First Interchangeable Biosimilar Approval for Lucentis®
On August 2, 2022, Coherus BioSciences announced that the U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all…
Take Stock: Federal Policy Watch
Washington Healthcare Update | June 13, 2022
By Stephanie A. Kennan, Gina Sherick, McGuireWoods LLP
This Week in Washington: House Passes FDA User Fee Reauthorization Package Congress House House to Consider the ARPA-H Act On June 20, the House will consider H.R. 5585, the…
Florida Intellectual Property Law Blog
Cosmetics FDA Florida IP
By John Rizvi
I Invented a Cosmetic Product. Do I Need FDA Approval? You developed a cosmetic product and you’re excited to get it on the market. But you’re new at this. You…
Napoli Shkolnik Blog
What Does “FDA-Approved” Really Mean?
When you see the term “FDA-approved” on a product, it’s easy to think that it’s been verified as safe and effective by the government agency. But what does that really…
Big Molecule Watch
FDA Accepts Regeneron and Sanofi’s DUPIXENT (Dupilumab) sBLA for Priority Review
By Grace Truong
Last week, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted a Priority Review of the supplemental Biologics License Application (sBLA) for DUPIXENT (dupilumab) 300 mg weekly to…
DC Medical Malpractice & Patient Safety Blog
FDA takes new fire for approving drugs too fast, with too little evidence
Taxpayers and lawmakers may be grasping just how far in the wrong direction the federal Food and Drug Administration has gone in approving prescription drugs for sale on U.S. markets…
Health Industry Washington Watch
Competing bills propose amendments to FDA’s accelerated approval program
By Brittney Cafero, Taber Rueter
The House Energy and Commerce Committee seems poised to make substantial changes to the Food and Drug Administration’s (“FDA’s”) Accelerated Approval Program. The committee’s Democratic chairman, Frank Pallone, Jr. (D-NJ)…
Medicaid and the Law
Oregon’s New Waiver Request to Exclude Accelerated Approval Drugs from Medicaid Coverage
Hello readers! Today’s post focuses on a topic we’ve touched on a few times in the past – Medicaid drug formularies. Back in December 2021, the state of Oregon released…
Health Law Prof Blog
Adaptive Approval of Drugs for Rare Diseases
Wendy Olsder (Eindhoven University of Technology), Tugce Martagan (Eindhoven University of Technology), Jan C. Fransoo (Tilburg University), Adaptive Approval of Drugs for Rare Diseases, SSRN (2021):Problem definition: Adaptive approval is…
The CLS Blue Sky Blog
Informed Options Trading Before FDA Approves Drugs May Be Growing Problem
By Zekun Wu, Paul Borochin, Joseph H. Golec
The Food and Drug Administration (FDA) appoints drug experts to drug advisory committees (ACs) that make approval or rejection recommendations for about half of all new drugs (usually the unique…