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Complete Response for Akebia Vadadustat

[ Price : $8.95]

FDA issues a complete response letter for Akebias vadadustat citing a negative benefit/risk assessment and safety concerns.

Panel Votes 6 to 4 to Reject Amylyx ALS Drug

[ Price : $8.95]

FDAs Peripheral and Central Nervous System Drugs Advisory Committee votes 6 to 4 that data from a single randomized, controlled tr...

CGMP Issues at Agropharma Laboratories

[ Price : $8.95]

FDA warns Salinas, Puerto Rico-based Agropharma Laboratories about repeat CGMP violations in its production of finished drugs.

FDA Approves 2nd mRNA Booster for Some Individuals

[ Price : $8.95]

FDA authorizes a second booster dose of the Pfizer and Moderna Covid-19 vaccines for older adults and some immunocompromised peopl...

Dr Retter CGMP Violations Cited

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FDA warns Mazowieckie, Poland-based Dr Retter Ec Wladyslaw Retter about CGMP violations in its production of over-the-counter drug...

Comments on Computational Modeling Guidance

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Three stakeholders submit general and specific comments on an FDA computational modeling and simulation draft guidance.

ViiVs Cabenuva Approved for HIV-1 in Adolescents

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FDA approves ViiV Healthcares Cabenuva (cabotegravir, rilpivirine) for treating HIV-1 in certain virologically suppressed adolesce...

Biobeat 510(k) for Expanded Wearable Patient Monitor

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FDA clears a Biobeat 510(k) for its wearable remote patient monitoring device to monitor respiratory rate and body temperature in ...

Stakeholders Comment on Digital Data Acquisition Draft

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Stakeholders give comments and suggestions to FDA on its draft guidance on using digital health technologies for remote data acqui...

Comments on FDA Device Transition Guidance

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Two medical device stakeholders comment on an FDA draft guidance to transition devices into normal compliance when the Covid-19 pu...