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Human User Safety in Animal Drugs Guidance

[ Price : $8.95]

FDA publishes a guidance explaining how CVM assesses human user safety in applicable animal drug applications.

Synapse Labs Studies Unacceptable: FDA

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FDA tells NDA and ANDA sponsors they must repeat clinical and bioanalytical studies conducted for their applications by Synapse La...

Praise, Suggestions for RWE Studies Guidance

[ Price : $8.95]

Six stakeholders express appreciation for and suggest improvements to an FDA draft guidance on using real-world evidence in non-in...

Medical Gas GMP, Safety Reporting Rule

[ Price : $8.95]

Federal Register notice: FDA issues a final rule revising its requirements for current good manufacturing practice, postmarketing ...

Clinical Hold on Zentalis Drug After 2 Deaths

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FDA places a partial clinical hold on three Zentalis Pharmaceuticals azenosertib studies after two recent deaths due to presumed s...

Elixir Breakthrough Status for Coronary Bioadapter

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FDA grants Elixir Medical a Breakthrough Device Designation for its novel bioadaptive implant DynamX Sirolimus-Eluting Coronary Bi...

Mercks Pneumococcal 21-Valent Vaccine Approved

[ Price : $8.95]

FDA grants Merck accelerated approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine) for preventing invasive disease and...

Akili OTC App Cleared for ADHD

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FDA clears an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactiv...

2023 Trial Diversity Workshop Report

[ Price : $8.95]

FDA publishes its report on an 11/2023 workshop on increasing clinical trial diversity.

Guide on ANDA Facility Inspection Readiness

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.