FDA Related News

Medical Devices

FDA Draft Guidance for Medical Devices Intended for Weight Loss

FDA posts a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations.

AI Has Saved FDA 17,000 Hours: Makary

FDA commissioner Marty Makary explains how the agency is using AI to modernize tedious tasks performed by humans to make drug reviews more efficient a...

Human Drugs

Sen. Johnson Probing FDA Rare Disease Denials

Senator Ron Johnson (R-WI) launches a congressional investigation into FDAs recent decisions to reject or delay treatments for rare diseases.

FDA General

FDA Opens New, Searchable Adverse Event Platform

FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on one searchable platf...

Human Drugs

FDA OKs Bristol Myers Squibbs Sotyktu for Psoriatic Arthritis

FDA approves Bristol Myers Squibs Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis.

4 Major Issues Plaguing FDA: Newsweek

A Newsweek report details four major issues it says have plagued FDA in its first year under commissioner Marty Makary.

Human Drugs

FDA Posts 483 Related to New Novo Nordisk Warning Letter

FDA releases the Form 483 behind a 3/5 Warning Letter to Novo Nordisk that cited serious violations of postmarketing adverse drug experience reporting...

Human Drugs

CGMP Violations in Tentamus India Inspection

FDA warns Indias Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.

Medical Devices

Advita Ortho Hit with 7 QS Violations

FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equinoxe Reverse Shoulder...

Human Drugs

Rosemont Pharma Gets Complete Response on Valacyclovir

FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.