FDA Related News

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FDA issues a draft guidance recommending training, record-keeping, and procedures for voluntary recalls of regulated products.

Human Drugs

FDA Concerned About 505(q) Resource Needs

FDA says it is concerned that Section 505(q) of the Federal Food, Drug, and Cosmetic Act does not discourage submission of citizen petitions intended ...

Medical Devices

Konica Minoltas Dynamic Digital Radiography Cleared

FDA clears a Konica Minolta Healthcare Americas 510(k) for its Dynamic Digital Radiography device.

Medical Devices

FDA Issues Surgical Staple Order, Guidance

FDA takes additional steps intended to improve safety of surgical staplers and staples for internal use.

Human Drugs

Changes Sought in Competitive Generics Guidance

Three stakeholders recommend changes to increase transparency and clarity in an FDA draft guidance on competitive generic therapies.