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CMC Development and Readiness Pilot

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Federal Register notice: FDA announces year three of its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pi...

3 FDA Guides on Device Accreditation Scheme for Conformity

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FDA posts three medical device-related draft guidances about the agencys Accreditation Scheme for Conformity Assessment Program.

Sanofis Sarclisa OKd for Multiple Myeloma

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FDA approves a Sanofi-Aventis supplemental BLA for Sarclisa (isatuximab-irfc) for use with bortezomib, lenalidomide, and dexametha...

FDA Revoking Outdated Mutual Recognition Pact

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Federal Register notice: FDA proposes to revoke the routdated egulations entitled Mutual Recognition of Pharmaceutical Good Manufa...

FDA OKs Rybrevant for Expanded Indication

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FDA approves a Johnson & Johnson supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemothera...

9 No-Longer-Marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of nine no-longer-marketed ANDAs from multiple applicants.

Adverse Event Reporting Info Collection Revised

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Federal Register notice: FDA seeks comments on an information collection revision entitled Postmarketing Adverse Experience Report...

Smiths Recalls ParaPAC Ventilators

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Smiths Medical recalls (Class 1) its ParaPAC plus P300 and P310 ventilators due to the possibility that patient outlet connectors ...

Vanda Hits FDA for Rejecting Tradipitant

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Vanda criticizes FDA for failing to approve its NDA for tradipitant to treat gastroparesis.

Panel to Discuss Seasonal and Avian Flu Preparedness

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Federal Register notice: FDA announces a 10/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss and ...