FDA Related News

Court Invalidates HHS Rule on DTC Pricing Disclosures

On the eve a rule was to go into effect to require drug pricing information in direct-to-consumer ads, the Washington, DC federal court rules that HHS...

Human Drugs

FDA Warns 3 API Repackers on CGMP Issues

FDA warns three API repackers about violations of current good manufacturing practice regulations.

Human Drugs

Compounded Oxitriptan Compliance Policy

FDA issues an immediate effect guidance explaining when it will exercise enforcement discretion for licensed pharmacists and doctors who use bulk oxit...

Human Drugs

Labeling Abuse and Dependence Guidance

FDA issues a draft guidance with recommendations for applicants to use in writing the Drug Abuse and Dependence section of labeling for human prescrip...

Human Drugs

Patient Labeling Use Guidance Out

FDA issues a draft guidance with recommendations for developing content and format of an Instructions for Use document for certain prescription drugs ...

Federal Register

Guide on Epidermolysis Bullosa Drug Development

Federal Register notice: FDA makes available a final guidance entitled Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifes...

Human Drugs

Fresenius Recalls Two Fluorouracil Lots

Fresenius Kabi USA recalls two lots of fluorouracil injection due to the potential for them to contain glass particulates.

Medical Devices

Edwards Recalls IntraClude Intra-Aortic Occlusion Device

Edwards LifeSciences recalls its IntraClude Intra-Aortic Occlusion Device due to balloon rupture risks during use.

Federal Register

Final Rule on CDRH Supervisory Review of Decisions

Federal Register notice: FDA issues a final rule to amend its regulations on internal agency supervisory review of certain decisions related to device...

Federal Register

Device GMP Advisory Committee Seeks Reps

Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of a nonvoting industry representat...