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Federal Register

OMB Approves 5 Information Collections

FDA announces that OMB has approved five information collection notices.

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Federal Register

Advisory Panel Rescheduled for Covid Therapy

Federal Register notice: FDA amends a 9/8 notice that announced a 10/6 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss Veru Inc.s for tu...

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Biologics

FDA Awards 5 Biosimilars Research Grants

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

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Human Drugs

Torrent Pharmaceuticals FDA-483

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

Human Drugs

Uneven Readiness Seen for Supply Chain Law

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

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Human Drugs

Jail for 2 Women in Clinical Trial Data Case

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

Biologics

FDA Authorizes Novavax Covid-19 Booster

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

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FDA General

CVMs Solomon Retiring at Year End

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

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Federal Register

Guide on AML Drug Development Considerations

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

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Federal Register

Draft Guide on Cancer Immunotherapeutic Trials

Federal Register notice: FDA makes available a draft guidance entitled Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in ...