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Post-Approval Safety Data Reporting Guide

[ Price : $8.95]

FDA publishes a draft ICH guidance on post-marketing individual case study reporting.

Advisors to Weigh Imetelstat Benefits, Risks

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FDA medical reviewers ask the Oncology Drug Advisory Committee to weigh the benefits of the benefits and serious risks of Gerons i...

ODAC Looking at Increased Deaths in 2 Drugs

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FDA asks the Oncologic Drugs Advisory Committee to evaluate the higher risk of early deaths in trials supporting sBLAs for Celgene...

Need to Creatively Regulate Software as Device: Atty.

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Mintz attorney Benjamin Zegarelli says FDA needs to develop creative ways to regulate software as a medical device while it waits ...

FDA Budgets to Expand Foreign Footprint

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FDA associate commissioner for global policy and strategy Mark Abdoo says the agency is requesting funds to begin expanding its fo...

Petition Seeks More Ozempic, Mounjaro Trials

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A petition submitted by a Charles Ludlam calls on FDA to require additional clinical trials to examine the loss of lean muscle mas...

Breakthrough Status for Anxiety Disorder Drug

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FDA grants MindMed a breakthrough designation for its MM120 (lysergide d-tartrate) program for treating generalized anxiety disord...

PhRMA Seeks Waivers on Patient Medication Info

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Pharmaceutical Research and Manufacturers of America says FDA should allow drug companies to seek waivers from the one-page patien...

Ensartinib NDA Accepted for Lung Cancer

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FDA accepts for review an Xcovery Holdings NDA for ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor for treating adult pa...

Drug Supply Small Dispenser Info Collection

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Federal Register notice: FDA seeks comments on a new proposed information collection entitled Proposed Small Dispensers Assessment...