FDA Related News

Medical Devices

End Medical Device Excise Tax: AdvaMed

AdvaMed CEO Scott Whitaker asks President Trump to support permanent elimination of the medical device excise tax that is set to return 1/1/20.

Human Drugs

Drug Quality Experiential Learning Site Visit Program

Federal Register notice: FDA announces that it is accepting invitations to participate in the Fiscal Year 2020 CDER Office of Pharmaceutical Quality S...

Federal Register

FDA/Health Canada ICH Public Meeting

Federal Register notice: FDA announces an 11/4 regional public meeting between Health Canada and FDA on the International Council for Harmonization ph...

Medical Devices

CDRH Proposes 27 FY 2020 Final, Draft Guidances

CDRH issues lists of final and draft guidances it expects to publish in FY 2020.

Nature City Settles FTC Claims for $537,500

The Federal Trade Commission says a Florida federal court has approved a settlement with Nature City over the companys false and unsubstantiated healt...

Human Drugs

Dont Use Cannabis When Pregnant, Breastfeeding: FDA

FDA cautions against use of cannabis products by women who are pregnant or breastfeeding.

Medical Devices

J&J, Ethicon Settle Mesh Marketing Suits for $116.9 Million

Pennsylvania attorney general Josh Shapiro says Johnson & Johnson and its Ethicon subsidiary have settled allegations of deceptive marketing of transv...

Human Drugs

Foamix Pharma NDA for Rosacea Foam Filed

FDA accepts for review a Foamix Pharmaceuticals NDA for FMX103 (minocycline topical foam 1.5%) topical foam for treating moderate-to-severe papulopust...

Human Drugs

Expanded Indication for Genentech Flu Drug

FDA approves a Genentech supplemental NDA for Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 12 years of age and o...

Human Drugs

Viatrexx Recalls Sterile Injectable Products

Viatrexx Bio recalls all products in 10 mL sterile injectable vials because they were manufactured in a manner that cannot guarantee their sterility.