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Combo Products Guide on Premarket Pathways

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Federal Register notice: FDA makes available a final guidance entitled Principles of Premarket Pathways for Combination Products....

FDA Renews Vaccine Advisory Committee

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Federal Register notice: FDA renews for an additional two years its Vaccines and Related Biological Products Advisory Committee.

Johnson Memorial Hit with 483 After Inspection

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FDA issues sterile drug product maker Johnson Memorial Cancer Center a Form FDA-483 after a 10/2021 inspection cited GMP deficienc...

103 Novel Devices Granted Authorizations in 2021

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A just-released CDRH annual report says it was able to grant marketing authorizations for 103 novel devices last year, despite bei...

Califf Agrees to Ethics Commitments to Bolster Nomination

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FDA commissioner nominee Robert Califf agrees to significant ethics commitments in a move to secure Senate support for his nominat...

Moderna Covid Vaccine Now Approved as Spikevax

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FDA grants full approval to Modernas Covid-19 vaccine under the name Spikevax for use in individuals 18 years of age and older.

Novavax Seeks EUA for Covid Vaccine

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Novavax has submitted an emergency use authorization for NVX-CoV2373, its protein-based Covid-19 vaccine candidate for adults 18 y...

Comments Extended on Device Modeling/Simulation Guide

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Federal Register notice: FDA extends the comment period for a 12/23 notice on a draft guidance entitled Assessing the Credibility ...

Info Collection on FDA Communications Testing

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Federal Register notice: FDA sends to OMB an information collection extension entitled Generic Clearance for Quantitative Testing ...

House Health Subcommittee Hearing on User Fee Agreements

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The House Energy and Commerce Committees Health Subcommittee announces a 2/3 user fee reauthorization hearing that will review FDA...