FDA Related News

Medical Devices

Hologic Laser Treatment Cleared on Double Chins

FDA clears a Hologic 510(k) for the body laser contouring product SculpSure to treat a double chin (submental area).

Federal Register

Mammography Quality Advisory Committee Renewed for 2 Years

Federal Register notice: FDA announces the renewal of the National Mammography Quality Assurance Advisory Committee.

Human Drugs

Steps to Close the Efficacy-Effectiveness Gap

A Health Affairs blog post looks at ways to close the gap between results seen in randomized clinical trials and those obtained from real-world eviden...

Human Drugs

Allergan Gets Refuse-to-File on Schizophrenia Drug

FDA issues Allergan a refuse-to-file letter on a supplemental NDA for Vraylar (cariprazine) for treating negative symptoms associated with schizophren...

Medical Devices

FDA Approves Abbotts Continuous Glucose Monitor

FDA approves an Abbott Diabetes Care PMA for the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that ...

Human Drugs

CGMP Violations at Chinas Shandong Vianor

FDA warns Chinas Shandong Vianor Biotech about CGMP violations in its production of finished pharmaceuticals.

Human Drugs

Translarna Effectiveness Not Persuasive: FDA

CDER medical reviewers say a PTC Therapeutics contested NDA for Translarna does not contain persuasive evidence for the drugs effectiveness in treatin...

Human Drugs

Hurricane Damage to Puerto Rico Likely to Cause Shortages: FDA

FDA worries about medical product shortages as the damage from a hurricane that devastated Puerto Rico is assessed as worse than first predicted.

Medical Devices

CDRH Seeing Patient Preference Benefits: Shuren

CDRH director Jeffrey Shuren and two colleagues say the Center has been using patient-focused data to help in the review of some medical device applic...

No Justification for Lack of Input on Informed Consent: Advocates

Public Citizen faults FDA for issuing a final guidance on changing informed consent requirements without an opportunity for public comment before it w...