FDA Related News

FDA Pushed to Release Company Application Data

NPR reports that transparency advocates are pushing FDA to release to the public more data from drug and medical device applications.

Human Drugs

CGMP Violations at Indias Torrent Pharmaceuticals

FDA warns Indias Torrent Pharmaceuticals about CGMP violations in its production of finished pharmaceuticals.

Human Drugs

Glenmark Pharmaceuticals CGMP Violations

FDA warns Indias Glenmark Pharmaceuticals about a CGMP violation in its production of finished pharmaceuticals.

Human Drugs

Inactive Ingredient Database Suggestions

Three stakeholders suggest changes to an FDA draft guidance on the inactive ingredient database.

Medical Devices

Meeting Transcript on Cybersecurity Patient Messaging

FDA makes available a transcript of a 9/10 Patient Engagement Advisory Committee that recommended the agency develop standards for device companies to...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Glenmark Pharmaceuticals, Torrent Pharmaceuticals, Coral Pharmaceuticals and Denterpris...

Human Drugs

Akorn Betamethasone Dipropionate Lotion Approved

FDA approves an Akorn ANDA for betamethasone dipropionate lotion USP, 0.05%, a corticosteroid indicated for relieving inflammatory and pruritic manife...

Medical Devices

QS Violations at Denterprise International

FDA warns Denterprise International about Quality System and Radiological Health violations in its work as a specification developer, manufacturer of ...

Human Drugs

FDA Zantac Impurity Info Sheet Out

FDA says it does not have scientific evidence on which to base a recommendation to continue using or discontinue Zantac due to the presence of NDMA im...

Human Drugs

Understanding FDA Patient Experience Data Use

Sanofi researchers analyze FDA use of patient experience data in 2018 new molecular entity approvals to establish a baseline for further study.