FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Federal Register

CDRH Seeks Experiential Learning Partners

Federal Register notice: CDRH announces its 2018 Experiential Learning Program.

Federal Register

Class 2 Designation for Organophosphate Test System

Federal Register notice: FDA classifies the organophosphate test system into Class 2 (special controls).

Medical Devices

FDA Grants, Denies Parts of Examination Glove Petition

FDA grants a Public Citizen petition to ban cornstarch powder in surgeons and patient examination gloves and denies its request to ban natural rubber ...

Medical Devices

FDA Digital Health Framework Raises Questions: Post

A Health Affairs blog post raises several questions about major policy changes in the FDA Digital Health Innovation Action Plan.

Human Drugs

Public Citizen Warns Against Azar at HHS

Public Citizen says that former Lilly executive Alex Azar, a potential candidate as HHS secretary, opposes steps to restrain drug prices and favors we...

Marketing

Bumper Ads Can Help Recall: CMI

Media resource CMI says YouTube bumper ads can be used strategically to tease new products, increase awareness of existing products, or support anothe...

Human Drugs

CDER Inspection/Review Leader Doleski Leaves for Sanofi

After 28 years at FDA, CDER Office of Process and Facilities (OPF) acting deputy director David Doleski leaves to accept the position of biologics com...

Human Drugs

FDA Priority Review for Lynparza sNDA for Breast Cancer

FDA accepts for priority review an AstraZeneca supplemental NDA for the use of Lynparza (olaparib) tablets in certain patients with germline BRCA-muta...

Human Drugs

Akorn 483s Released

FDA releases two identical FDA-483s issued to Akorn, Inc., with three inspection observations.

Human Drugs

Pacira sNDA Resubmitted on Exparel for Pain

FDA accepts a Pacira Pharmaceuticals supplemental NDA resubmission seeking expansion of its Exparel (bupivacaine liposome injectable suspension) label...