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Medical Devices

AdvaMed Recommends Appraisal Program Improvements

AdvaMed recommends ways to improve CDRHs voluntary medical device manufacturing and product quality program.

Federal Register

CDRH Guidance Document Listing

Federal Register notice: FDA announces the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fiscal...

Federal Register

Guidance on Drug Name Placement/Prominence in Ads

Federal Register notice: FDA makes available a guidance entitled Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisemen...

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Fagron Compounding Services, RC Outsourcing and Seindni Co.

Human Drugs

CDER Outlines Internal Research on 3D-printed Drug Products

CDERs Office of Testing and Research outlines research it is conducting to better understand 3D or additive manufacturings use in making drug products...

Medical Devices

FDA Approves Intersect PMA for Sinuva

FDA approves an Intersect ENT PMA for the Sinuva (mometasone furoate) Sinus Implant, a new targeted approach to treating recurrent nasal polyp disease...

Federal Register

Comments Sought on FDA Fellowship Program Apps

Federal Register notice: FDA seeks comments on an information collection extension for FDA Application for Participation in FDA Fellowship Programs (F...

Name Placement in Drug Ads Final Guidance

FDA posts a final guidance on Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements for drugs.

Human Drugs

Janssen Files sNDA for Xarelto Cardiovascular Benefits

Janssen Research & Development submits a supplemental NDA for two new Xarelto (rivaroxaban) vascular indications: reducing the risk of major cardiovas...

Medical Devices

FDA Modernizing 510(k), Other Device Review Processes

FDA says it will publish early next year a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence to meet...