FDA Related News

Medical Devices

FDA OKs J&Js Tecnis PureSee Lens for Cataract Surgery

FDA approves Johnson & Johnsons Tecnis PureSee Intraocular Lens, a new extended depth-of-focus lens for use in cataract surgery.

Human Drugs

Attorneys Discuss New FDA Draft NCI Guidance

Two Axinn attorneys explain a new FDA draft guidance on new clinical investigation exclusivity and ways that some NDA and sNDA applicants may be able ...

Human Drugs

Continue Modernizing Foreign Inspections: Study

Academic researchers call on FDA to continue to modernize its foreign drug inspection program and overcome differences in inspection intensity between...

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FDA Draft Guidance for Medical Devices Intended for Weight Loss

FDA posts a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations.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