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Bristol Myers sNDA for Camzyos

[ Price : $8.95]

FDA accepts for review a Bristol Myers Squibb supplemental NDA for Camzyos (mavacamten) for an expanded indication to reduce the n...

FDA Releases Guidances on Generic Topical Drugs

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FDA posts three FDA draft guidances that provide general recommendations for physicochemical and structural characterization tests...

Paper Calls for FDA Reforms on Transparency/Evidence

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A white paper commissioned by Georgetown University says changes are needed at FDA because its evidence standards have become dist...

Medtronic Pacing Lead Gets Expanded Labeling

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FDA approves expanded labeling on Medtronics SelectSecure MRI SureScan Model 3830 cardiac lead for conduction system pacing.

Real-World Evidence Program Announced

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Federal Register notice: FDA announces the Advancing Real-World Evidence (RWE) Program, which was agreed to under the recent user ...

PhRMA Raises QMM, KASA Issues

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PhRMA raises issues about the CDER Quality Management Maturity and Knowledge-Aided Assessment and Structured Application programs ...

Comments Extended on Animal Generic User Fees

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Federal Register notice: FDA extends the comment period associated with a 9/30 notice on the proposed recommendations for the reau...

Guide on GMPs for Animal Cell/Tissue Products

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Federal Register notice: FDA makes available a final guidance #253 entitled Current Good Manufacturing Practice for Animal Cells, ...

Multiple Clinical Trial Endpoints Guidance

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FDA publishes a guidance on accounting for multiple endpoints in the analysis of drug and biologic clinical trials.

Talaris Reports FREEDOM-1 Study Death

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Talaris says it has informed FDA about the death of a subject in the FREEDOM-1 trial of FCR001 in live donor kidney transplant rec...