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Info Collection on Rx Drug Labeling

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Federal Register notice: FDA seeks comments on an information collection revision entitled Labeling Requirements for Prescription ...

Pfizer Booster Vaccine Panel Meeting Details

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Federal Register notice: FDA announces a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Pfi...

CDER Starts Novel Excipient Review Pilot Program

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CDER starts its Novel Excipient Review Pilot Program to foster the development of excipients for when excipient manufacturers and ...

Objectionable Conditions Found in Kaleido Inspection

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FDA warns Kaleido Biosciences that it conducted clinical trials on an investigational Covid-19 drug without submitting an IND.

FDA Clinical Hold on BioMarin Phearless Study

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FDA places a clinical hold on a BioMarin gene therapy study to treat adults with phenylketonuria.

FDA Accepts 2 Submissions for Sickle Cell Drug

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FDA accepts for priority review a Global Blood Therapeutics supplemental NDA and a separate NDA for Oxbryta (voxelotor) and its us...

NeuroOne Medical Brain Electrodes Cleared

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FDA clears a NeuroOne Medical Technologies 510(k) for its Evo sEEG Electrode technology for temporary (less than 24 hours) use for...

Skinny Label Effectively Dead: Attorney

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Attorney Sara Koblitz says the generic drug industry has been upended by a Federal Circuit Court of Appeals ruling that Teva induc...

10 Observations in Toyobo FDA-483

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FDA releases the FDA-483 with 10 observations from an inspection at Japans Toyobo Co.

Panel to Weigh Future of Multiple Myeloma Therapy

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Federal Register notice: A 10/28 advisory committee discusses whether an accelerated approval for an Oncopeptides NDA for Pepaxto ...