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Two Imbruvica Accelerated Approvals Withdrawn

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Janssen Biotech and Pharmacyclics decide to voluntarily withdraw two accelerated approval indications for Imbruvica (ibrutinib) t...

Rep. Kim Reintroduces Drug Recall Authority Bill

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U.S. Representative Andy Kim (D-NJ) reintroduces a bill to provide FDA with mandatory recall authority for any and all faulty or u...

Florida Gets $600K in Cochlear Implants Case

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Florida wins a $600,000 payment to the states Medicaid program under a multistate action against cochlear implants maker Advanced ...

FDA Explores AI Image Analysis for Complex Drugs

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FDA explores whether it can enter into a five-year contract with an entity that can perform non-invasive high-resolution imaging a...

Boost Faith in Accelerated Approvals: Researchers

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Yale University researchers suggest five steps FDA could consider to help build patient and clinician trust in drug accelerated ap...

RSVpreF Vaccine Meets Endpoints

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Pfizer-supported research shows its investigational bivalent RSV prefusion F protein-based vaccine succeeded in preventing RSV-ass...

Mutagenic Impurities Guideline Adopted

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The International Council for Harmonization gives final approval to a guidance on assessing and controlling mutagenic impurities i...

FDA Wants MDUFA 5 PPI Input

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FDA asks for input on five questions that could be included in a revision of a medical device patient perspective guidance.

Comments Extended on Neurodevelopmental Study Guide

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Federal Register notice: FDA extends the comment period for a draft guidance entitled Considerations for Long-Term Clinical Neurod...

Untitled Letter Sent to Fidia Pharma

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CBER issues an untitled letter to Fidia Pharma USA after reviewing the companys Web sites and determining that its cell/tissue pro...