FDA Related News

Stakeholders Comment on Patient Preference Guide

Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total produce lifecycle.

Human Drugs

Furosemide Injection sNDA Faces Submission Delay

scPharmaceuticals says a planned supplemental NDA submission of an autoinjector as an alternative to the current on-body infusor used with its Furosci...

Federal Register

FDA Science Board Renewed for 2 Years

Federal Register notice: FDA announces the renewal of its Science Board for an additional two years.

Human Drugs

CDER Wants AI Use in Drug Safety: Attorneys

Troutman Pepper attorneys explain the potential benefits in FDAs new Emerging Drug Safety Technology Program.

Human Drugs

Advisory Panel to Discuss Pediatric RSV Vaccine Safety

FDA plans to ask its Vaccines and Related Biological Products Advisory Committee to discuss potential safety concerns related to pediatric respiratory...

Human Drugs

NIH Ends Mpox Study Early

The National Institutes of Health ends a trial of an mpox antiviral drug that failed to produce an efficacy signal.

Human Drugs

Carvykti Shows Favorable Minimal Residual Disease Data

Johnson & Johnson reports data from its Phase 3 CARTITUDE-4 study that show Carvykti significantly increased minimal residual disease (MRD) negativity...

Human Drugs

OCI Case Nets 2 on HIV, Covid Drug Convictions

Two men are convicted of securities fraud in a case involving misrepresented submissions to FDA for a drug purportedly intended to treat HIV and Covid...

Human Drugs

CGMP Violations at Chinas Guangzhou Four Es

FDA warns Chinas Guangzhou Four Es Scientific Co. about CGMP violations in its production of finished drugs.