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FDA Sticking with Vaccine Guidance: Hahn

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Speaking at a Financial Times conference, FDA commissioner Stephen Hahn says the agency will follow guidelines it has given to ind...

Breast Implant Labeling Guidance

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FDA issues a guidance on the content and format for some labeling information for breast implants.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Intrathecal Compounding Specialist and Panacea Biotec.

Questions, Answers on 2 ICH Guidances

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FDA issues a draft guidance with questions and answers for two International Council for Harmonization guidances.

Center for Research on Complex Generics Grant

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FDA awards a $5 million grant to two universities to create a Center for Research on Complex Generics.

Study Questions REMS Effectiveness in Opioid Crisis

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The HHS Inspector General says REMS are not well suited to quickly address the opioid crisis and makes four recommendations to imp...

FDA Should Up Transparency to Gain Public Trust: Column

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Former FDA principal deputy commissioner Joshua Sharfstein and two co-authors suggest four ways FDA could recommit to greater tran...

Guidance on Drug Importation

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Federal Register notice: FDA makes available a final guidance entitled Importation of Certain FDA-Approved Human Prescription Drug...

Inovio Covid-19 Vaccine Trial on Partial Hold

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FDA places a partial clinical hold on an Inovio planned Phase 2/3 trial of its Covid-19 vaccine candidate INO-4800, including its ...

ANDA Amendments for Tentatively Approvals

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FDA issues a guidance entitled ANDA Submissions Amendments and Requests for Final Approval to Tentatively Approved ANDAs.