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Federal Register

Guide on UDI Direct Device Markings

Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Direct Marking of Devices.

Human Drugs

FDA Approves Kalos AUVI-Q for Infants

FDA approves a Kalo supplemental NDA for AUVI-Q (epinephrine injection, USP) 0.1 mg, for treating life-threatening allergic reactions, including anaph...

Medical Devices

Medtronic Azure Pacemakers with BlueSync Approved

FDA approves a Medtronic PMA for its Azure pacemakers with BlueSync technology.

Federal Register

Comments Extended on Cardiac Troponin Assays

Federal Register notice: FDA extends its comment period provided in a 7/31 Federal Register notice entitled Cardiac Troponin Assays; Public Workshop; ...

Federal Register

Comments Sought on Petition for OTC Denture Repair Kits

Federal Register notice: FDA seeks comments on a petition from an undisclosed applicant requesting exemption from premarket notification requirements ...

Federal Register

Guide on Same Procedure Exception for Tissue Products

Federal Register notice: FDA makes available a guidance on Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding ...

Federal Register

Guide on HCT/P Minimal Manipulation and Homologous Use

Federal Register notice: FDA makes available a guidance entitled Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Pro...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 11/17/2017.

Federal Register

Guide on Cell/Tissue-Based Product Regulatory Considerations

FDA releases a guidance on Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation a...

Rep. DeLauro Seeks Ban on DTC Ads, Again

Congresswoman Rosa DeLauro (D-CT) reintroduces a bill (HR 4385) that would amend the Food, Drug, and Cosmetic Act to restrict direct-to-consumer drug ...