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Human Drugs

Pfizer Healthcare India CGMP Violation

FDA warns Pfizer Healthcare India about a CGMP violation in its production of finished drugs.

Medical Devices

CME BodyGuard Infusion Pump Recalled

CME America recalls the BodyGuard Infusion Pump Systems because the pumps may under or over infuse medications.

Human Drugs

PhRMA Rare Disease Day Comments

PhRMA submits additional comments on the FDA 2/24 Rare Disease Day public meeting.

Human Drugs

Novartis Not Penalized for Zolgensma Violations

FDA ends its probe of Novartis Zolgensma data manipulation and waives any regulatory action against the company.

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.

Human Drugs

Emergency Use Allows for Unapproved Drug Use

Amid controversy over President Trumps support for the drug, FDA reverses itself to issue an emergency use authorization to permit the off-label use o...