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ICH M9 Biopharmaceutics Biowaivers Q&A Guidance

[ Price : $8.95]

FDA publishes an International Council for Harmonization question-and-answer guidance on the M9 guidance on biopharmaceutics class...

Panel to Review AstraZeneca RSV Therapy

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Federal Register notice: FDA announces a 6/8 Antimicrobial Drugs Advisory Committee meeting to discuss an AstraZeneca BLA for nirs...

Info Collection on Dietary Supplement GMPs

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Current Good Manufacturing Practice in Manu...

Rentschler Biopharma Germany Site 483

[ Price : $8.95]

FDA leaves a five-item Form FDA-483 after a 2/27-3/7 inspection of Rentschler Biopharmas manufacturing facility in Baden-Wurttembe...

Lilly Eyes Fast OK for Donanemab in Alzheimers

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Rejected by FDA for accelerated approval, Lilly says it will seek the fastest traditional approval possible for its donanemab to t...

GSK Wins Approval for 1st RSV Vaccine

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FDA approves a GlaxoSmithKline BLA for Arexvy (respiratory syncytial virus vaccine, adjuvanted), for preventing lower respiratory ...

ICH Quality Risk Management Guidance Published

[ Price : $8.95]

FDA publishes the International Council for Harmonization Q9(R1) foundational quality risk management guidance.

Innovative Manufacturing Approaches Notice Corrected

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Federal Register notice: FDA corrects a 4/24 notice entitled Advancing the Utilization and Supporting the Implementation of Innova...

PDUFA User Fee Assessment Guidance

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FDA publishes a guidance on its assessment of user fees under PDUFA 7.

Reps. Question FDA Pace for New Covid Therapeutics

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Reps. Trahan and Crenshaw challenge FDAs ability to timely approve new preventive and therapeutic products to counter new Covid-19...