FDA Related News

Federal Register

Guide on Container Labeling Safety Considerations

Federal Register notice: FDA makes available a final guidance entitled Safety Considerations for Container Labels and Carton Labeling Design to Minimi...

Biologics

Consultants Submit Draft AAV Guidance to FDA

Dark Horse Consulting Group submits a draft gene therapy guidance to FDA developed by former CBER staffer Donald Fink in consultation with other exper...

Improving Trial Representation Book

The National Academies produces a book on improving representation for women and minorities in clinical trials and research.

Human Drugs

Apollo Care FDA-483

FDA releases the FDA-483 with five observations from an inspection at the Columbia, MO-based Apollo Care outsourcing facility.

Federal Register

Guide on Generic User Fee Assessments

Federal Register notice: FDA makes available a final guidance entitled Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.

Human Drugs

Senate Bill to Restore FDA Orphan Drug Interpretation

Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduce legislation entitled the Retaining Access and Restoring Exclusivity (RARE) Act, which ...

FDA General

Senate Draft User Fee Bill Sets IVD Regulation

The Senate HELP Committee releases a discussion draft of a bill that would reauthorize user fee programs for another five years and enhance certain ot...

Human Drugs

Clinical Hold Lifted on Gilead HIV Therapy

FDA removes a clinical hold on Gilead Sciences injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis.

Human Drugs

FDA Hits Lupins Novel Labs with 13-item 483

A March FDA inspection of Novel Laboratories (dba Lupin Somerset) leads to a 13-item FDA Form-483 that cites significant and repeat GMP deficiencies.

Human Drugs

FDA Rejects EUA for Fluvoxamine in Covid

FDA rejects an emergency use authorization request filed by University of Minnesota Medical School infectious disease physician David Boulware and oth...