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Vertex Wins Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA issues a priority review voucher to Vertex Pharmaceutical for Trikafta (elexacaftor/tezacaftor/ivacaf...

Final Guide on Device Consensus Standards

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Federal Register notice: FDA makes available a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards...

Information Collections Approved by OMB

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Federal Register notice: FDA posts a list of information collections that have been approved by OMB under the Paperwork Reduction ...

Drug Labeling Geriatric Information Guidance

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FDA publishes a draft guidance with updated recommendations for including geriatric information in the labeling for prescription h...

CGMP Violations, Deviations at Mayons Pharmaceuticals

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FDA warns Indias Mayons Pharmaceuticals about CGMP issues in its manufacturing of finished drugs and APIs.

FDA, CDC Have Lost Bill Gates Trust

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Bill Gates says he no longer has trust in FDA and CDC as independent regulators because of the way they have responded to Trump ad...

CBER Lists 29 Guidances in CY 2020 Agenda

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An updated CBER guidance agenda for 2020 lists 29 planned guidances in four categories.

GEs Shatterproof Bulk Package for Contrast Agent OKd

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FDA approves GE Healthcares shatterproof polymer +PLUSPAK Pharmacy Bulk Package for use with its macrocyclic gadolinium-based MRI ...

Comments on IND Communications with FDA

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Three drug industry stakeholders give FDA feedback on its public meeting on an independent assessment of FDA-sponsor IND communica...

FDA Turns Down Mallinckrodt NDA for Terlipressin

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FDA sends Mallinckrodt a complete response letter on its NDA for terlipressin and its use in treating adults with hepatorenal synd...