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Updated CDER Guidance Agenda

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CDER posts an updated 2024 guidance agenda listing 101 guidances in 17 categories.

M12 Drug Interaction Q&A

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FDA publishes an International Council on Harmonization Question and Answer guidance to clarify its M12 guidance on drug interacti...

Durbin, Cassidy Introduce Drug Competition Bill

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Sens. Durbin and Cassidy introduce the bipartisan REMEDY Act to discourage innovator drug companies from filing additional patents...

FDA Clears Teleflex Perfusion Balloon Catheter

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FDA clears a Teleflex 510(k) for its Ringer Perfusion Balloon Catheter for use in percutaneous transluminal coronary angioplasty p...

Psychopharmacologic Drugs Panel Renewal

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Federal Register notice: FDA renews its Psychopharmacologic Drugs Advisory Committee for an additional two years beyond the charte...

FDA Explains New LabelComp Tool

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FDA says its new LabelComp artificial intelligence tool automates the identification of adverse event changes in drug labeling upd...

FDA OKs Expanded Jemperli Indication

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FDA approves an sBLA expanding the endometrial cancer indication for GlaxoSmithKlines Jemperli.

Abbott Device Correction on FreeStyle Libre 3

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Abbott issues a medical device correction for a small number of FreeStyle Libre 3 sensors because they may provide incorrect high ...

Novartis Sues FDA to Reverse Generic Entresto OK

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Novartis files a lawsuit against FDA that seeks to reverse the agencys recent approval of MSN Laboratories generic version of Nova...

Telix Pharma Hit with Refuse-to-File on BLA

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FDA sends Telix Pharmaceuticals a refuse-to-file letter on its BLA for TLX250-CDx (89Zr-DFO-girentuximab), an investigational imag...