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Human Drugs

CGMP Violations at Australias Delta Laboratories

FDA warns Australias Delta Laboratories about CGMP violations in its production of finished pharmaceuticals.

Federal Register

Guide on UDI Enforcement Discretion for Certain Devices

Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Policy Regarding Compliance Dates for Class I and Uncla...

Federal Register

Workshop on Device Conformity Assessment to Recognized Standards

Federal Register notice: FDA announces a 5/22-23 public workshop on Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognize...

Federal Register

Rule on Intended Use Changes Delayed for More Consideration

Federal Register notice: FDA proposes to delay the effective date of certain portions of a final rule that amended the agencys existing regulations de...

Human Drugs

FDA, Defense Dept. Launch Drug Development Program

FDA starts a collaborative program with the Defense Department to prioritize development and approval of medical products needed by U.S. troops.

Human Drugs

CGMP Violations at Shanwei Honghui Daily Appliance Co.

FDA warns Chinas Shanwei Honghui Daily Appliance Co. about CGMP violations in its manufacturing of finished pharmaceuticals.

Human Drugs

Safety Alert Issued on Tesaros Varubi

An FDA drug safety alert says Tesaros Varubi (rolapitant) injectable emulsion has been associated with anaphylaxis and other serious hypersensitivity ...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Becton Dickinson, Delta Laboratories, Schrofner Cosmetics, Shanwei Honghui Daily Applia...

Medical Devices

2nd Fraudulent Medical Device Guilty Plea

The Justice Department says a second person has pleaded guilty to conspiring to market and distribute laser devices by falsely claiming they could cur...

Human Drugs

Gottlieb Unveils New Transparency Initiatives

FDA launches a new pilot to offer more transparency with drug approval decisions, among other initiatives to help understand the agencys regulatory ac...