FDA Related News

Medical Devices

FDA Launches Digital Health Center of Excellence

FDA says it is launching a Digital Health Center of Excellence within CDRH.

Human Drugs

Coupler Enterprises CGMP Inspection Violations

FDA warns Coupler Enterprises about CGMP violations in its manufacturing of finished drugs.

FDA Amending Medical Product Intended Use Regs

FDA says it will update regulations to clarify the types of evidence it considers when determining the intended use of a medical product.

Federal Register

Draft Guide on Cannabidiol Bioequivalence

Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance for Cannabidiol.

Federal Register

Meeting on Sex and Gender Differences with CBD

Federal Register notice: FDA announces an 11/19 public meeting Webcast entitled CBD and Other Cannabinoids: Sex and Gender Differences in Use and Resp...

Human Drugs

Safety Alert on Perrigo Albuterol Inhalers

FDA alerts health care professionals and patients to a recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma So...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Coupler Enterprises and HNC Products.

Biologics

Tighter Covid Vaccine Approval Standards Coming: Report

The Washington Post reports that FDA will issue a new guidance for Covid-19 vaccines that will tighten emergency authorization standards and most like...

Medical Devices

Spineology Gains De Novo for OptiMesh

FDA grants Spineology Inc. a de novo marketing authorization for its OptiMesh Expandable Interbody Fusion System.

Human Drugs

Q&A Content Added to Clinical Trial Guidance

FDA adds content to a question-and-answer appendix in its guidance entitled Conduct of Clinical Trials of Medical Products during COVID-19 Public Heal...