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FDA Sees No New Nuplazid Risks

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FDA says its review of deaths and adverse events associated with Acadias Nuplazid did not show any new or unexpected safety findin...

Advanced Manufacturing Technology Grants

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FDA awards five grants for improvements to continuous manufacturing of biological products.

Field Correction on Altitude-affected Balloon Pumps

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Getinge begins a field correction on about 5,223 Maquet/Getinge Cardiosave intra-aortic balloon pumps due to a potential interrupt...

FDA Disagrees with Breast Implant Safety Findings

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FDA disputes findings published in the Annals of Surgery that suggested an increased risk of certain connective tissue conditions,...

11 Observations on Zhejiang Huahai FDA-483

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FDA releases an FDA-483 with 11 observations from an inspection at Chinas Zhejiang Huahai Pharmaceutical Co.

3 Observations in Strides Pharma Science Inspection

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FDA completes a pre-approval product inspection at Indias Strides Pharma Sciences with three inspection observations.

OBI Pharma Granted Orphan Status for Leukemia Drug

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FDA grants OBI Pharma an orphan drug designation for OBI-3424 for treating acute lymphoblastic leukemia.

Q&A Guide on Product Identifiers

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Federal Register notice: FDA makes available a draft guidance entitled Product Identifiers Under the Drug Supply Chain Security Ac...

Clinical Trials Penalties Guidance

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FDA describes its approach to seeking civil money penalties from those failing to follow ClinicalTrials.gov submission requirement...

CTTI Releases Real-World Evidence Meeting Summary

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The Clinical Trials Transformation Initiative reports on its public meeting on best practices and needed resources for advancing u...