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Attorney Questions Supplement Mandatory Listing

[ Price : $8.95]

Attorney Marc Ullman argues against a proposal for mandatory dietary supplement listing with FDA as a way to improve agency enforc...

Guilty Plea in Compounded Drug Kickback Scheme

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The Justice Department says a Florida man pleaded guilty to one count of conspiracy to violate the anti-kickback law through a com...

Bavarian Nordic Breakthrough for RSV Vaccine

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FDA grants Bavarian Nordic A/S a breakthrough therapy designation for vaccine candidate MVA-BN RSV for preventing lower respirator...

FDA Fast Track for UCSF Gene Therapy

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FDA gives Regenerative Medicine Advanced Therapy designation to a University of California San Francisco gene therapy treatment fo...

Cell/Gene Therapy Panel to Hear Research Update

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Federal Register notice: FDA announces a 3/10 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to hear an overview ...

Radiation Safety Standards Panel Industry Reps

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Federal Register notice: FDA seeks industry organizations to help in selecting voting industry representatives to serve on CDRHs T...

Intended Use Reg Neednt Curb Production: Attorneys

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Two Dechert attorneys say businesses accounting for off-label uses of a drug or medical device when deciding how much to produce n...

Drug eSubmission Data Standards Updated

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Federal Register notice: CDER and CBER annouces that 2/15 is the date that support begins for version 3.1.1 of the Clinical Data I...

Rare Disease Endpoint Advancement Pilot

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A Medill News Service report says part of the upcoming PDUFA reauthorization could be a Rare Disease Endpoint Advancement pilot pr...

Comments on Visible Particulate Inspection Guidance

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Three stakeholders comment on an FDA draft guidance on visual inspection of injectable products for visible particulates.