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CGMP Deviations at Aurobindo Facility

[ Price : $8.95]

FDA warns Aurobindo Pharmaceutical about repeat CGMP deviations in the manufacturing of active pharmaceutical ingredients at its p...

Dissident FDA Vaccines Deputy Joins Adjuvance Technologies

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Former dissident CBER Office of Vaccines Research and Review deputy director Philip Krause joins Adjuvance Technologies as a strat...

Medical Device Study Patient Engagement Guidance

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FDA publishes a guidance on using patient engagement to support the design and conduct of medical device clinical studies.

Vaccines Panel Meets to Pick Flu Vaccine Strains

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Federal Register notice: FDA announces a 3/3 Vaccines and Related Biological Products Advisory Committee meeting that will select ...

CBER Plans 13 Guidances in 2022

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CBER releases a list of 13 guidances it is considering developing in 2022.

Soleno Needs Another Trial for NDA Filing: FDA

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FDA tells Soleno Therapeutics that an additional clinical trial is necessary before the company submits an NDA for once-daily DCCR...

Pfizer/BioNTech Begin Omicron Vaccine Study

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Pfizer and BioNTech begin a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine can...

Medical Device PRO Guidance

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FDA publishes a guidance on using patient-reported outcome instruments in medical device evaluation.

Health Plus Inspection Violations

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FDA warns Chino, CA-based Health Plus about CGMP violations in its manufacturing of finished pharmaceuticals.

Comments on Real-World Data Guidance

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Four stakeholders suggest changes to a draft FDA guidance on using electronic health records and claims data to support drug and b...