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Multiple Violations at Adept Life Science

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FDA warns Chandler, AZ-based Adept Life Science about CGMP and misbranding violations in its production of dietary supplements.

GDUFA 2022 Science and Research Report

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FDA issues the FY 2022 GDUFA Science and Research Report with information on projects in 13 scientific areas.

Improve Biosimilar Development and Approval Efficiency

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Two FDAers introduce a journal issue exploring ways in which clinical pharmacology innovations can expand the development and appr...

Externally Controlled Trial Guidance

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FDA publishes a draft guidance with considerations for designing and conducting externally controlled trials for drug and biologic...

FDA 'Defying' Appeals Court is Troubling: Attorneys

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Two Epstein Becker attorneys say an FDA statement challenging the 11th Circuit Court of Appeals application of its position on orp...

CBER 2023 Guidance Agenda

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FDA publishes its 2023 guidance agenda listing 11 guidances it is considering developing this year.

Biden Administration Ending Public Health Emergency 5/11

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The Biden Administration announces that it will end the current Covid-19 public health emergency declaration and national emergenc...

CBER Tissues/Advanced Therapies Director Bryan Retiring

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After more than 22 years at FDA, CBER Office of Tissues and Advanced Therapies director Wilson Bryan announces he is retiring in M...

Califf Proposes Transformation of Foods Program, ORA

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FDA commissioner Robert Califf announces a new transformative vision for the agencys human foods program and the Office of Regulat...

2 EUAs Granted for Mpox Diagnostics

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Federal Register notice: FDA announces the issuance of two Emergency Use Authorizations for diagnostic devices intended for use du...