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Expand Some Islet Cell Transplantation Access: Senators

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Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type...

Data from First 100 QMSR Inspections Analyzed

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Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 FDA inspections under the new ...

Guide on Immunogenicity Data Submissions for Pharmacokinetic Reviews

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FDA releases a guidance that is intended to assist industry in the submission of datasets from clinical studies that evaluate immu...

Senator Seeks FDA Records on Covid Vaccine Safety Review

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Sen. Ron Johnson (R-WI) launches a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from...

Committee Backs Moderna Flu Vaccine

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The FDA Vaccines and Related Biological Products Advisory Committee votes to support Moderns mRNA flu vaccine mFlusiva.

FDA Wants Testosterone Therapy Labels Updated

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HHS says FDA is seeking labeling changes for testosterone replacement therapy products to reflect current scientific and clinical ...

Review Memo Dismisses Hoegs Block on Tzield Approval

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FDA posts an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi su...

Grace Therapeutics Preparing NDA Resubmission

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Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April.

FDA Updates Device READI-Home Innovation Challenge Initiative

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FDA posts additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate developme...

Evaluate Generic Bicalutamide Manufacturers: Petition

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A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient s...