FDA Related News

Medical Devices

Orchestra Bio Breakthrough Status for Virtue Balloon

FDA grants Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-eluting Balloon for treating coronary in-stent restenosis.

Human Drugs

Empire Distributors Selling Unapproved New Drug: FDA

FDA warns Empire Distributors it is illegally marketing an unapproved new drug that also is misbranded.

FDA General

Public Citizen Asks SCOTUS Not to Weaken FOIA

Public Citizen and others ask the Supreme Court not to grant a broader exemption to the Freedom of Information Act sought by the Food Marketing Instit...

Medical Devices

Changes Suggested for Device Inspection Feedback Guidance

AdvaMed asks FDA to make changes to improve its draft guidance on non-binding feedback after medical device establishment inspections.

Human Drugs

CDER Biopharmaceutics Council MAPP

CDER issues a MAPP with policies and procedures for its new Biopharmaceutics Council.

Medical Devices

Braun Medicals Heparin Pre-filled Syringe OKd

FDA approves B. Braun Medicals 5,000-unit prefilled heparin sodium injection, USP.

Federal Register

Public Meeting on Drug Benefit-Risk Assessment Approaches

Federal Register notice: FDA has announced a 5/16 public meeting entitled Characterizing FDAs Approach to Benefit-Risk Assessment Throughout the Medic...

Federal Register

Panel to Review Tuberculosis NDA

Federal Register notice: FDA announces a 6/6 Antimicrobial Drugs Advisory Committee meeting to discuss a Global Alliance for TB Drug Development NDA f...

Federal Register

Surgical Staplers Reclassified from Class 1 to Class 2

Federal Register notice: FDA proposes to reclassify surgical staplers for internal use from Class 1 (general controls) into Class 2 (special controls)...

Draft Voluntary Recall Guidance

FDA issues a draft guidance recommending training, record-keeping, and procedures for voluntary recalls of regulated products.