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Unit-Dose Expiration Dating Guidance

[ Price : $8.95]

FDA issues a guidance explaining when the agency will not take action regarding requiring stability studies for repackaged product...

Pregnancy, Lactation, Reproduction Draft Guidance

[ Price : $8.95]

FDA issues a draft guidance to help applicants comply with content and format requirements for drug label subsections on pregnancy...

Breast Cancer Endpoint Guidance

[ Price : $8.95]

FDA issues a guidance on using pathological complete response as an endpoint for accelerated approval of drugs to treat high-risk ...

Pacira Paying $3.5 Million for FCA Kickback Charges

[ Price : $8.95]

The Justice Department says Pacira Pharmaceuticals is paying $3.5 million to resolve a whistleblower charge that it provided kickb...

Neocis Yomi Edentulous Indication Cleared

[ Price : $8.95]

FDA clears a Neocis 510(k) for a new Yomi edentulous indication for its robot-assisted dental surgery system.

CDER Updates Inactive Ingredient Database

[ Price : $8.95]

FDA updates its inactive ingredient database to allow users to perform electronic queries to obtain accurate maximum daily exposur...

CARES Provision Should Speed OTC Changes: FDA

[ Price : $8.95]

FDA tells the GAO that a provision in the CARES Act should help it address more quickly safety issues in OTC drugs.

New EUA Template for Outside a Lab Covid Tests

[ Price : $8.95]

FDA posts a new template for commercial developers to help them develop and submit emergency use authorization requests for Covid-...

Orthopedic/Rehabilitation Devices Panel Meeting 9/8-9

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Federal Register notice: FDA announces a 9/8-9 virtual Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory...

Covid Test EUAs Deadliest Regulatory Overreach: Article

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Two law professors say FDAs guidances on emergency use authorization for laboratory-developed Covid tests was a major regulatory o...