FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Medical Devices

FDA Clears Bausch Contact Lens Rehydrating Drops

FDA clears a Bausch + Lomb 510(k) for its Biotrue Hydration Boost Contact Lens Rehydrating drops.

latest-news-card-1
Medical Devices

Doc Group Wants FDA Probe of Musks Neuralink

The Physicians Committee for Responsible Medicine calls on FDA to investigate possible good laboratory practice violations by Elon Musks Neuralink in ...

latest-news-card-1
Federal Register

Info Collection on Device Quality System Regulation

Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices: Current Good Manufacturing Practice Quality Sy...

latest-news-card-1
Medical Devices

Smiths Device Correction on CADD Infusion System

Smiths Medical sends an urgent medical device correction letter identifying two potential issues with CADD Infusion System Infusion Sets.

Animal Drugs

CVM Sees 1% Decrease in Food Animal Antimicrobial Use

CVM posts its 2021 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals that shows antimicrobial drug sales for such...

latest-news-card-1
Medical Devices

Academics Urge FDA to Simplify Breast Density Notifications

A JAMA viewpoint article urges FDA to appropriately test for readability and general literacy its breast density notification language that was mandat...

latest-news-card-1
Human Drugs

DoJ Indictment on Unapproved Drugs

The Department of Justice announces an indictment charging Marina Sievert (Dunedin, FL) with introducing into interstate commerce an unapproved new dr...

latest-news-card-1
Medical Devices

Some Medical Gloves Removed From Shortage List

FDA updates its device shortage list to remove medical gloves (product codes LYY, LYZ, LZA, and LZC) that were in short supply due to the Covid-19 pan...

latest-news-card-1
Human Drugs

Panel Meeting to Discuss Isotretinoin iPLEDGE REMS Program

FDA announces a 3/28-29/2023 advisory committee meeting to discuss proposed changes to the iPLEDGE Risk Evaluation and Mitigation Strategy for acne dr...

latest-news-card-1
Human Drugs

FDA Hits 2 QuVA Pharma Facilities with 483s

FDA releases two Form FDA-483s after inspecting QuVa Pharma outsourcing facilities in New Jersey and Texas.