FDA Webview
X
about-us-banner

FDA Related News

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

Non-Spinal Orthopedic Plate 510(k) Guidance

FDA publishes a draft guidance with recommendations for 510(k) submissions for orthopedic non-spinal bone plate, screw, and washer devices.

latest-news-card-1
Human Drugs

Court Orders Release of FDA Vanda Info

The DC federal court orders FDA to give Vanda Pharmaceuticals information from its review of a Vanda sNDA for a new Hetlioz indication.

latest-news-card-1
Human Drugs

IND Not Submitted for Cornea Associates Trials: FDA

FDA warns Dallas, TX-based Cornea Associates about conducting clinical investigations without submitting a required IND.

latest-news-card-1
Human Drugs

Merck Touts New Keytruda Endometrial Cancer Data

Merck says it will meet with regulatory authorities about an expanded indication after reporting Phase 3 trial results of Keytruda in certain endometr...

latest-news-card-1
Human Drugs

House Committee Questions FDA Drug Shortage Actions

The leadership of the House Energy and Commerce Committee and two of its subcommittees asks FDA for detailed drug shortage information about 10 specif...

latest-news-card-1
Federal Register

Guide on Contact Lens Submissions

Federal Register notice: FDA makes available a final guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety a...

latest-news-card-1
Federal Register

Guide on Animal Studies for Devices

Federal Register notice: FDA makes available a final guidance entitled General Considerations for Animal Studies Intended to Evaluate Medical Devices....

latest-news-card-1
Biologics

Cell, Gene Therapy Application Backlog Questioned

The chair and ranking member of the House Energy and Commerce Health subcommittee ask CBER director Peter Marks for detailed information on FDA clinic...

latest-news-card-1
Biologics

Bipartisan Bill on Interchangeable Biologics

Four U.S. Representatives introduce the Biologics Competition Act, a bipartisan bill that would order HHS to evaluate the process by which interchange...

latest-news-card-1
Human Drugs

GSK Will Seek Expanded Use for Jemperli

GSK says it plans to submit a BLA supplement by 7/1 after reporting interim results from a Phase 3 trial investigating Jemperli (dostarlimab) plus sta...