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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FDA Revoking Outdated Mutual Recognition Pact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...

Medical Device Biocompatibility Guidance

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FDA publishes a draft guidance with recommended chemical analyses for medical device biocompatibility assessment.

Device User Fee Cover Sheet Info Collections

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Federal Register notice: FDA submits to OMB information collection revisions entitled Medical Device User Fee Cover Sheet, Form FD...

RFK Jr. to Recommend Trump Health Agency Heads?

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Mainstream health gadfly Robert K. Kennedy, Jr., says he has been asked by Donald Trump to be heavily involved in choosing people ...

CDER Biosim. Interchangeability Change Explained

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CDER director Patrizia Cavazzoni and Office of Therapeutic Biologics and Biosimilars director Sarah Yim say a revised FDA guidance...

Elanco Gets Anti-Itch Zenrelia Approved for Dogs

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FDA approves Elanco Animal Healths Zenrelia (ilunocitinib tablets), a once-daily oral JAK inhibitor for controlling itching associ...