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Drug Compounding Registration Info Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Registration of Human Drug Compounding...

FDA Denies St. Jude Codeine Use Petition

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FDA denies a St. Jude Childrens Research Hospital request to allow some use of codeine-containing analgesics in patients under age...

More Supplements Risk Oversight Coming: Califf

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FDA commissioner Robert Califf says dietary supplement risk management will be elevated with the integration of the Office of Diet...

Oncopeptides Appealing Drug Withdrawal Request

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Oncopeptides says it is going to file a formal appeal of FDAs recent request for the company to voluntarily withdraw its accelerat...

Priority Review for Venatorx UTI Drug NDA

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FDA sets 2/22/2024 as the PDUFA action date for its priority review of Venatorx Pharmaceuticals NDA for cefepime-taniborbactam to ...

Breakthrough Status for AngioVac System

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FDA grants AngioDynamics a breakthrough device designation for its AngioVac System and its proposed indication for use to include ...

Knoll Debarred by FDA for 5 Years

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Federal Register notice: FDA debars Ildiko M. Knoll for five years from importing or offering for import any drug into the U.S.

Florida Amends FOIA Lawsuit Against FDA

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Florida amends a lawsuit against FDA charging the agency with violating the Freedom of Information Act by withholding records requ...

Clinical Hold on AML Cell Therapy

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FDA places a clinical hold on a 2seventy bio Phase 1 study (PLAT-08) of SC-DARIC33 in acute myeloid leukemia after a patient death...

FDA Extends Review of Chikungunya Vaccine

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FDA extends by three months the review of a Valneva BLA for VLA1553, the companys chikungunya virus vaccine candidate.