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Comments Sought on Supplement AERs/Recordkeeping Info

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a collection of information associated with adverse event reporting and recordkeepi...

Comments Sought on Requesting CDRH Review of Decisions

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on information collection associated with processes for stakeholders to request additi...

Comments Sought on Device Inspection Accredited Persons

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a collection of information on device inspections by accredited persons.

Guidance on Device Manufacturing Site Change Supplements

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Manufacturing Site Change Supplements: Content and Submission.

Coronary Vascular Simulation Software into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies the coronary vascular physiologic simulation software device into Class 2.

23andMe Gains Clearance for Controversial Genetic Test

[ Price : $8.95]

FDA clears 23andMes Personal Genome Service, a controversial genetic test that was as the center of a CDRH regulatory action two y...

FDA Needs Updated Regulatory Framework: Patient Group

[ Price : $8.95]

Friends of Cancer Research founder Helen Sigal says FDAs regulatory framework for drugs and devices needs to be updated to reflect...

Package Type Guidance Out

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FDA issues a draft guidance revising definitions for packaging types and adding a new definition.

Stop Apotex Neulasta Biosim, Amgen Asks Court

[ Price : $8.95]

Amgen asks a Florida federal court to approve an injunction barring Apotex from marketing its Neulasta biosimilar until it gives a...

AZs Lesinurad Side Effects Raised for Committee

[ Price : $8.95]

FDA medical reviewers tell the Arthritis Advisory Committee that they have questions about the safety of AstraZenecas new gout dru...