FDA Related News

Medical Devices

FDA Real-World Evidence Guide Stirs Critics

Five stakeholders make suggestions for changes to an FDA draft guidance on using real-world evidence in medical device regulatory decision-making.

Medical Devices

More Companies Should Join TAP: Shuren

CDRH director Jeffrey Shuren urges more medical device companies to join the Total Product Lifestyle Advisory Program.

3 E&C Dems Urge FDA Issue Trial Diversity Guide

Democratic leaders of the House Energy and Commerce Committee urge FDA to promptly issue the overdue draft guidance on drug and medical device clinica...

Medical Devices

FDA Posts Medtronic Endotracheal Tube Update

FDA posts a Medtronic update on its NIM electromyogram endotracheal tubes, including actions to take in the event of airway obstruction.

Human Drugs

Alert on Smartwatches Measuring Blood Glucose

An FDA safety alert warns about the risks related to using smartwatches or smart rings that claim to measure blood glucose levels without piercing the...

Biologics

sBLA for Tecvayli OKd for Reduced Dosing

FDA approves a Johnson & Johnson supplemental BLA for Tecvayli (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks in patie...

Human Drugs

United Therapeutics Sues FDA Over Liquidia NDA

United Therapeutics sues FDA over its decision to permit Liquidia to seek a second indication for its Yutrepia by amending its pending NDA rather than...

Federal Register

Digital Health Advisory Committee Established

Federal Register notice: FDA amends its standing advisory committee regulations to add the new Digital Health Advisory Committee.

Medical Devices

Vet Third-Party Device Data: FDA

FDA cautions device manufacturers to evaluate the performance data provided by third-party labs for use in agency submissions.

Human Drugs

CBER Postmarket Requirement/Commitment SOPP

CBER publishes a SOPP for the administrative handling, review, and reporting of postmarketing requirements and commitment submissions.