With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh Circuit has upheld the orphan exclusivity for Catalyst Pharmaceuticals, Inc....more
On November 20, 2020, the U.S. Health and Human Services Department (HHS) announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs Initiative (UDI)....more
On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more
7/15/2020
/ Affordable Care Act ,
Biologics ,
Biosimilars ,
Biotechnology ,
BPCIA ,
Constitutional Challenges ,
Department of Justice (DOJ) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
SCOTUS ,
Severability Doctrine ,
Tax Cuts and Jobs Act ,
Trump Administration
Opinion highlights importance of a "clear" record at FDA -
On 20 May the U.S. Supreme Court unanimously ruled that federal preemption questions arising under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are for a...more
5/30/2019
/ Agency Disapproval ,
Clear Evidence Standard ,
Failure To Warn ,
FDA Approval ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Jury Trial ,
Manufacturers ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Preemption ,
Prescription Drugs ,
Question of Fact ,
Question of Law ,
Remand ,
SCOTUS ,
State Law Claims ,
Vacated ,
Warning Labels
Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more
2/22/2019
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
FDA Reauthorization Act ,
FDARA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Exclusivity ,
Regulatory Agenda ,
Regulatory Oversight ,
Reversal
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more