FDA Related News

Human Drugs

GDUFA Post-Warning Letter Meeting Guidance

FDA publishes a guidance on its implementation of the post-Warning Letter meeting established in the GDUFA 3 commitment letter to allow eligible facil...

Open Bipartisan Probe of RFK Vaccine Plans: Pallone

House Energy and Commerce Committee ranking Democrat Frank Pallone calls for a bipartisan committee investigation of HHS secretary Robert Kennedys act...

Biologics

CBERs Prasad Named Chief Medical/Scientific Officer

CBER director Vinay Prasad has been appointed as FDAs chief medical and scientific officer, a new combination role for commissioner Marty Makary.

Human Drugs

Commissioners National Priority Voucher Program

FDA launches the Commissioners National Priority Vouchers to speed drug reviews for companies with products that are aligned with national priorities ...

Human Drugs

Aldeyra Files NDA Resubmission for Dry Eye Drug

Aldeyra Therapeutics resubmits an NDA for reproxalap to treat the signs and symptoms of dry eye disease.

Human Drugs

Zhejiang Huahai Pharmaceutical CGMP Issues

FDA warns Chinas Zhejiang Huahai Pharmaceutical Co. about CGMP violations in its production of finished drugs.

Human Drugs

OIG Hit FDA Accelerated Approvals

The latest semiannual report issued by the HHS Office of Inspector General raises questions about specific FDA accelerated drug approvals.

Human Drugs

FDA Allows Companies to Skip Import Bans: Report

A ProPublica investigative report details how a secret small group of FDA officials has approved exemptions for products from overseas factories that ...

Medical Devices

Multiple Violations at Reset Technology Corp.

FDA warns Irving, TX-based Reset Technology Corp. about Quality System and other violations in its production of two dental devices.

Human Drugs

Elevidys Shipping Nixed After 2nd Liver‑Failure Death

Sarepta Therapeutics halts shipments of its gene therapy Elevidys (delandistrogene moxeparvovec‑rokl) to non‑ambulatory Duchen...