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Limited, Not Full-scale Booster Shots Mulled

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FDA cautions that it may only be able to give the green light for booster shots later this month to those vaccinated with the Pfiz...

Milestone Reached on Competitive Generic Therapies

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CDER Office of Generic Drugs reaches the milestone of approving more than 100 generic drug applications with a Competitive Generic...

Panel to Discuss Pfizer Booster Vaccine 9/17

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FDA announces a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss Pfizer-BioNTechs supplemental ...

FDA Approves 6-Month Schizophrenia Drug

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FDA approves Janssens Invega Hafyera six-month atypical antipsychotic injection for some adult schizophrenia patients.

FDA Refusing to Approve ITCA 650

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FDA posts a Federal Register notice of its intent to not approve an Intarcia NDA for a diabetes drug/device combination product.

Info Collection on Device Establishment Fees

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Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device User Fee Cover Sheet, Form FD...

Drug Supply Security Info Collection

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Federal Register notice: FDA seeks comments on an information collection revision entitled Drug Supply Chain Security Act Implemen...

Omeza 510(k) for Collagen Wound Matrix

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FDA clears an Omeza 510(k) for its Omeza Collagen Matrix for chronic wound care.

Fraser Joins Greenberg Traurig

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Former FDA associate chief counsel for litigation James Fraser joins Greenberg Traurig.

Moderna Submits Covid Vaccine Booster Data to FDA

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Moderna submits trial data to FDA for an evaluation of its Covid vaccine booster shot.