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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.

AstraZeneca Gets 1st OPDP 2023 Warning Letter

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The CDER Office of Prescription Drug Promotion warns AstraZeneca that a sales aid for its Breztri misrepresents the drugs efficacy...

Informed Consent Guidance

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FDA publishes a guidance on the roles of IRBs, clinical investigators, sponsors, and FDA in informed consent for clinical investig...

QS Violations at TEI Biosciences

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FDA warns Boston, MA-based TEI Biosciences about Quality System violations in its manufacturing of collagen-based products.

Hold Lifted on Arcellx Myeloma Drug

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FDA removes a partial clinical hold against an Arcellx IND for CART-ddBCMA, an investigational drug for treating patients with rel...

FDA Approves Hepzato for Uveal Melanoma

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FDA approves Delcath Systems Hepzato Kit (melphalan for injection/hepatic delivery system) for liver-directed treatment in adult p...

Info Collection Revision on BLA Procedures

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Federal Register notice: FDA sends to OMB an information collection revision entitled Biologics License Applications (BLAs) Proced...

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...