FDA Related News

FDA Less Aggressive with Off-label Promotion: Woodcock

CDER director Janet Woodcock acknowledges that the pendulum has swung away from aggressive FDA drug advertising and promotion enforcement.

Federal Register

Patient Engagement Advisory Committee Meeting

Federal Register notice: FDA announces an 11/15 Patient Engagement Advisory Committee meeting to discuss and make recommendations on the topic Connect...

Human Drugs

CDER Priorities Include New Drugs Modernization

CDER director Janet Woodcock says her top priorities include modernizing the new drug review program and hiring a permanent director for the Office of...

Human Drugs

FDA Awards 12 Grants for Rare Disease Studies

FDA awards 12 new clinical trial research grants totaling more than $18 million over the next four years to help develop medical products for patients...

Medical Devices

Guide on 510(k) Benefit-Risk Factors

FDA issues a final guidance entitled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) wit...

Human Drugs

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 9/21/2018.

Human Drugs

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Joint Panel to Review Alkermes Depression NDA

Federal Register notice: FDA announces an 11/1 joint advisory committee meeting to review an Alkermes NDA for major depressive disorder.

Biologics

Pfizer Breakthrough Therapy Designation for Pneumococcal Vaccine

FDA grants Pfizer a Breakthrough Therapy designation for its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077.

FDA General

Midterms Threaten FDA Funding: Alliance

An analysis by the Alliance for a Stronger FDA says that the agencys fiscal year 2019 appropriations, which are part of a four-bill minibus, are imper...