FDA Related News

Human Drugs

Court Backs Vascepa ANDAs

Nevadas federal court rules against Amarin in a patent dispute with two generic drug companies over its Vascepa heart drug.

Human Drugs

FDA Accelerated Coronavirus Treatment Program

FDA describes its Coronavirus Treatment Acceleration Program to speed the development and deployment of Covid-19 therapies.

Human Drugs

BMS/Bluebird BLA for Multiple Myeloma

FDA accepts a Bristol Myers Squibb and Bluebird Bio BLA for idecabtagene vicleucel, a B-cell maturation antigen-directed chimeric antigen receptor T c...

Replace Global Medical Supply Chain: Economist

Coalition for a Prosperous America chief economist Jeff Ferry calls for significant cuts in the countrys reliance on overseas production of drugs and ...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Ficosota, Pfizer Healthcare India and Trilogy Laboratories.

Medical Devices

Enforcement Policy on Sterilizers, Disinfectant Devices

FDA posts a guidance on Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (Covid-19) Pub...

Federal Register

FDA Actions on Animal Drug Submissions

Federal Register notice: FDA amends its animal drug regulations to reflect recent application-related actions for new animal drug applications and abb...

FDA Pleased with $80 million in Stimulus Bill

FDA says it is pleased with an additional $80 million from the just-signed $2 trillion stimulus package that will fund some of its Covid-19 response e...

Guide on Product Shortage Reporting Responsibility

FDA posts a guidance on Notifying FDA about a medical product discontinuance or interruption in manufacturing.

Human Drugs

Clinical Trial Challenges from Covid-19: Q & A

FDA issues an updated guidance entitled Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic to add an appendix on common questions...