FDA Related News

Human Drugs

HIV Drug Product Draft Guidance

FDA issues a draft guidance to help sponsors develop systemic drug products for HIV-1 pre-exposure prophylaxis.

Human Drugs

FDA Bans Drugs with Isometheptene

FDA says distributors of drug products containing isometheptene, considered to be unapproved new drugs, agreed to cease distribution as of 1/1.

Medical Devices

Draft Lubricious Coating Wire Guidance

FDA issues a draft guidance on information to be included in labeling for PMAs or 510(k)s for devices containing lubricious coatings used in the vascu...

Medical Devices

Draft Guidewire Test and Labeling Guidance

FDA issues for comment a draft guidance to aid industry in designing and executing appropriate performance testing for three types of guidewires.

Federal Register

Brain Trauma Assessment Tests are Class 2

Federal Register notice: FDA classifies brain trauma assessment tests into Class 2 (special controls).

Federal Register

Endoscopic Cutting Systems Placed in Class 2

Federal Register notice: FDA classifies the endoscopic electrosurgical clip cutting system into Class 2 (special controls).

Federal Register

Draft Guide on Patient-Focused Drug Development

Federal Register notice: FDA makes available a draft guidance entitled Patient-Focused Drug Development: Collecting Comprehensive and Representative I...

Federal Register

Draft Guide on Humanitarian Device Exemption Program

Federal Register notice: FDA makes available a draft guidance entitled Humanitarian Device Exemption (HDE) Program.

CBER Going to Secure E-Mail

CBER says it will use secure e-mail for regulatory communications with sponsors as of 10/1.

Medical Devices

LivaNovas MEMO 4D Mitral Annuloplasty Ring Cleared

FDA clears a LivaNova 510(k) for its MEMO 4D semi-rigid mitral annuloplasty ring.