FDA Related News

Human Drugs

Genzyme Ireland Inspection Documents CGMP Issue

FDA warns Genzyme Ireland about the failure of the firms quality control unit to ensure that drugs comply with CGMP requirements.

Medical Devices

Abiomed Impella Heart Pump Recall is Class 1

FDA says the Abiomed recall of certain Impella CP Sets with SmartAssist is Class 1.

Medical Devices

Insulet Omnipod Pod Recall is Class 1: FDA

FDA says an Insulet recall of specific lots of its Omnipod Pods is Class 1.

Human Drugs

FDA Selects 7 PreCheck Pilot Participants

FDA selects seven companies from 80 applications to participate in the agencys PreCheck Pilot Program to advance U.S. drug manufacturing.

Human Drugs

Next-Generation Sequencing Data Submission Guidance

FDA publishes a guidance on submitting next-generation sequencing data to CDERs Division of Antivirals.

Human Drugs

FDA OKs Blood Cancer Drug Tregzi

FDA approves Orca Biosystems Tregzi to improve chronic graft-versus-host disease (GVHD)-free survival in adults with blood cancers undergoing allogene...

Human Drugs

CGMP Issues at Indias Wizcure Pharmaa

FDA warns Indias Wizcure Pharmaa about CGMP violations in its production of over-the-counter drugs.

Human Drugs

Chinese Drug Firm Refuses FDA Record Request

FDA warns Chinas Yangzhou Hongshengding Chemical Co. about not responding to agency requests for records on its over-the-counter drug manufacturing op...

CBER SOPP on Implementing, Managing REMS

CBER publishes a Standard Operating Policy and Procedure on implementing and maintaining REMS.

Human Drugs

FDA Novel Drug Approvals Remain Steady in 2026 First Half

FDA approval numbers show it approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consistent with recent year...