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FDA Awards 5 Biosimilars Research Grants

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FDA announces five new research projects funded by the Biosimilar User Fee Act.

Torrent Pharmaceuticals FDA-483

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FDA releases the form FDA-483 issued following an inspection at Indias Torrent Pharmaceuticals.

Uneven Readiness Seen for Supply Chain Law

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An HDA Research Foundation survey documents uneven readiness for the 2023 implementation milestone for the Drug Supply Chain Secur...

Jail for 2 Women in Clinical Trial Data Case

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A Florida federal judge sentences two former Tellus Clinical Research employees to jail time and restitution for their role in a c...

FDA Authorizes Novavax Covid-19 Booster

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FDA grants Novavax an emergency use authorization for its Novavax Covid‑19 Vaccine, Adjuvanted as a first booster dose for c...

CVMs Solomon Retiring at Year End

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Center for Veterinary Medicine director Steven Solomon announces his retirement, effective at the end of the year.

Guide on AML Drug Development Considerations

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Federal Register notice: FDA makes available a final guidance entitled Acute Myeloid Leukemia: Developing Drugs and Biological Pro...

Draft Guide on Cancer Immunotherapeutic Trials

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Federal Register notice: FDA makes available a draft guidance entitled Characterizing, Collecting, and Reporting Immune-Mediated A...

Oncology Guide on Tissue Agnostic Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Tissue Agnostic Drug Development in Oncology.

Quality System, Other Violations at Forcemech

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FDA warns Pearland, TX-based Forcemech International about Quality System and other violations in its importation and distribution...