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FDA Suddenly Cancels Crucial Flu Vaccine Meeting

[ Price : $8.95]

In a move linked to HHS secretary Robert F. Kennedy Jr., FDA suddenly cancels a 3/13-planned Vaccines and Related Biological Produ...

Fast-Track for Adicet Systemic Sclerosis Drug

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FDA grants fast-track designation for Adicet Bios ADT-001 to treat systemic sclerosis.

19-Page Exela Pharma Sciences FDA-483

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FDA releases the 19-page form FDA-483 with 15 observations from an inspection at the Exela Pharma Sciences outsourcing facility in...

FDA Clears Visby Respiratory Health Test

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FDA clears a Visby Medical 510(k) for its point-of-care test for detecting respiratory infections caused by influenza A & B, and C...

Bill to Block LDT Regulation

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Reps. Finstad and Crenshaw introduce legislation to stop FDA from regulating laboratory-developed tests.

FDA Warns Indias Granules Generic Drug Company

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An Indian news service says FDA has sent a Warning Letter to drug manufacturer Granules following a 2024 inspection at the firms f...

Ventec Recalls VOCSN Ventilators

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Ventec Life Systems recalls its VOCSN Multi-Function Ventilators because the devices were serviced using incorrect parts which can...

Makary FDA Confirmation Hearing Set for 3/6

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The Senate Health Education Labor & Pensions committee sets a 3/6 confirmation hearing to review the nomination of Johns Hopkins s...

7 Observations in Zhejiang Huahai FDA-483

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FDA releases the form FDA-483 with seven observations from an inspection at Chinas Zhejiang Huahai API manufacturing facility.

6 Observations on Piramal Pharma FDA-483

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FDA releases the form FDA-483 with six observations from an inspection at Indias Piramal Pharma API manufacturing facility.