FDA Related News

Human Drugs

Panel Backs Descovy for Preventing HIV in Men

An FDA advisory committee has voted 16-2 to recommend approval for Gilead Sciences HIV drug Descovy for pre-exposure prophylaxis (PrEP) in men and tra...

Human Drugs

Grassley Wants Unannounced Foreign Drug Inspections

Sen. Grassley asks FDA to resume unannounced inspections at foreign drug manufacturing facilities.

Human Drugs

Fabry Disease Drug Development Guidance

FDA issues a draft guidance on developing drugs to treat Fabry Disease.

FDA to Research Provider Boxed Warning Perceptions

CDERs Office of Prescription Drug Promotion says it will survey healthcare providers to learn how they receive, process, and use Boxed Warning and oth...

Marketing

Healthcare Providers Value Reprints: Report

A CMI Media doctor survey shows that providers want to receive current medical news and clinical information and can access a variety of media.

Federal Register

Annual Report on Postmarketing Requirements

Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...

Federal Register

FDA Revokes Emergency Use OK for Zika Test

Federal Register notice: FDA revokes an Emergency Use Authorization issued to InBios International for the ZIKV Detect 2.0 IgM Capture ELISA test.

Federal Register

Annual Report on Closed Advisory Panel Meetings

Federal Register notice: FDA releases an annual report on agency advisory committees that held closed meetings during fiscal year 2018.

Medical Devices

FDA Warns on Paclitaxel-coated Devices Mortality Signal

In an 8/7 letter to physicians, FDA says updates to device labeling and clinical trial informed consent documents are coming because of ongoing concer...

Human Drugs

FDA Funding Rare Disease Data Platform Meeting

FDA funds a meeting to launch a new rare disease data analytics platform.