FDA Related News

Marketing

DTC Ad Enforcement to Increase Under Trump: Panel

Lawyers on a Food & Drug Law Institute enforcement panel warn that the incoming Trump administration is likely to target and seek increased enforcemen...

Federal Register

FDA Revokes EUAs for B.Braun Covid Devices

Federal Register notice: FDA announces the revocation of B. Braun Medical emergency use authorizations for three Covid-related devices.

Regulating AI in Healthcare: Paragon White Paper

A Paragon Health Institute white paper suggests an approach to regulating healthcare artificial intelligence that it says builds on existing FDA regul...

Human Drugs

NeuroSense Gets FDA Agreement for ALS Study

Based on FDA feedback, NeuroSense Therapeutics says it will begin a Phase 3 study of PrimeC (ciprofloxacin and celecoxib) for treating amyotrophic lat...

Medical Devices

Fresenius Kabi Pump Early Alert

CDRH issues an early alert on a Fresenius Kabi high-risk Ivenix large-volume pump issue, the Centers first alert under a new communications pilot prog...

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Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total produce lifecycle.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