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18-Page FDA-483 on Ipca Laboratories Inspection

[ Price : $8.95]

FDA releases the form FDA-483 with 11 observations from an inspection at Indias Ipca Laboratories Ratlam API facility.

BioMarin Gene Therapy for Hemophilia A OKd

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FDA approves a BioMarin Pharmaceutical BLA for Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for treating adults with s...

Alvotech Complete Response Due to Inspection

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FDA sends Alvotech a complete response letter for its BLA for AVT02, a high-concentration biosimilar candidate referencing AbbVies...

2 Roche Assays Cleared for Alzheimers

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FDA clears two Roche assays that measure two biomarkers of Alzheimer's pathology beta-amyloid and tau proteins in adults over 55...

Prioritize Cancer Trial Diversity: Researchers

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FDAs Oncology Center of Excellence and other researchers stress the need to prospectively improve the diversity of cancer trial pa...

Cresilon Hemostatic Gel Cleared

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FDA clears a Cresilon 510(k) for Cresilon Hemostatic Gel to rapidly control bleeding without the need for manual pressure.

Orthopedic Implant Guide Guidance

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FDA publishes a draft guidance with recommendations on information to go in regulatory submissions for patient-matched guides to o...

Oncology Drug Approval Trends

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FDA and National Cancer Institute researchers document an increase in oncology drug approvals since 2000 that they expect to conti...

CBER Updates 2023 Guidance Agenda

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CBER issues a revised guidance agenda for 2023 with 13 likely guidances in three categories.

3 GOP Senators Push FDA on Chinese Cancer Drugs

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Republican Sens. Scott, Vance, and Braun criticize FDAs decision to allow the importation of some Chinese-approved cancer drugs to...