FDA Related News

Federal Register

Comments Sought on WHO Recommendations for Narcotic Scheduling

Federal Register Notice: FDA seeks comments on recommendations by the World Health Organization to impose international manufacturing and distributing...

Human Drugs

Galena Updates Federal False Claims Act Probe

Galena Biopharma says in an updated SEC filing that it is under civil and criminal investigations for marketing practices relating to its Abstral.

FDA General

Califf Leaving Post on Inauguration Day

FDA commissioner Robert Califf plans to officially resign on Inauguration Days (1/20), according to the agency.

Human Drugs

Merck, Incyte Advancing Combination Tumor Drug Program

Merck and Incyte Corp. announce plans to advance the clinical development program investigating the combination of epacadostat, Incytes investigationa...

Biologics

CBER Enhanced Operational Efficiency in FY 2016: Marks

CBER director Peter Marks says the Center met FY 2016 review timeframes for 100% of standard and priority BLA and NDA reviews.

Marketing

FTC Charges Deceptive Claims for Prevagen Supplement

The Federal Trade Commission and New York attorney general say that marketers for the dietary supplement Prevagen made false and misleading claims in ...

Human Drugs

FDA Approves Arymo ER With Some Abuse Deterrence

FDA approves Egalets Arymo ER, an extended-release opioid with abuse-deterrence properties for the injection route.

FDA Encouraging Clinical Trial Participation, Diversity

FDA says it is taking steps to encourage greater participation and more diversity in clinical trials.

Human Drugs

Guidance on OTC Acetaminophen Product Skin Reaction Warnings

FDA releases a guidance on Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious S...

FDA Guide on Combination Product GMP Compliance

FDA makes available a final guidance entitled Current Good Manufacturing Practice Requirements for Combination Products.