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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.

Indoco Remedies FDA-483 Released

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FDA releases the form FDA-483 with seven observations from an inspection at Indias Indoco Remedies manufacturing facility for ster...

Camizestrant in Breast Cancer Meets Primary Endpoint

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Data from an AstraZeneca interim analysis of its SERENA-6 Phase 3 breast cancer trial show that camizestrant in combination with a...

Google Watch Cleared for Pulse Loss Detection

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FDA clears a Google 510(k) for its Loss of Pulse Detection feature and its use on the Pixel Watch 3.

CDER Touts FY 2024 Drug Safety Activities

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CDERs 10th yearly drug safety report highlights the FY 2024 establishment of two new units contributing to drug safety.