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FDA Warns Centaur on CGMP Issues

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FDA warns Centaur Pharmaceuticals about CGMP issues in its manufacturing of drugs at its facility in Maharashtra, India.

Advancing RWE Program Deadline Coming

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FDA says the deadline for submissions for the next cycle of the Advancing Real-World Evidence program is 9/30.

PEPFAR Antiretroviral Drug Guidance

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FDA publishes a draft guidance with recommendations for single-entity and fixed-combination antiretroviral drugs to be distributed...

Broader Scientific Topics for Advisory Panels: Bumpus

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FDA chief scientist Namandj Bumpus says the agency is looking to revamp its advisory committees to convene panels that will solici...

FDA Revises Forms 356h and 1571

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FDA revises form 356h: Application to Market a New or Abbreviated New Drug or Biologic for Human Use and form 1571: Investigationa...

Decentralized Clinical Trial Comments

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Three drug and medical device industry trade associations comment positively on an FDA draft guidance on decentralized clinical tr...

Lonsurf & Bevacizumab OKd in Colon Cancer

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FDA approves Taiho Oncologys Lonsurf (trifluridine and tipiracil) with bevacizumab for treating certain metastatic colorectal canc...

BD Respiratory Viral Panel Gets Clearance

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FDA converts a BD Respiratory Viral Panel from an emergency use authorization to a cleared 510(k) for detecting Covid-19, influenz...

Baxter Recalls SIGMA Infusion Pumps

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Baxter Healthcare recalls its SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems ...

Progesterone Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that progesterone injection, USP, 50 mg/mL, was not withdrawn due to safety or effectivene...