Jill McCrory RN

Faegre Drinker Biddle & Reath LLP

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Latest Posts › Food and Drug Administration (FDA)

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FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more

12/2/2020 / Biosimilars , BPCIA , Draft Guidance , Food and Drug Administration (FDA) , Labeling , Licenses , Pharmaceutical Industry , Public Comment

FDA Expands Use of Certain Non-Cleared Electronic Thermometers During COVID-19 Public Health Emergency

On April 4, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance on “Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The...more

4/9/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , Public Health Emergency

Food and Drug Administration Issues Product Labeling, Advertising Draft Guidance for Prescription Biological Reference and...

The Food and Drug Administration’s (FDA) recent draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers,” offers insight and...more

3/12/2020 / Advertising , Biologics , Biosimilars , Food and Drug Administration (FDA) , Labeling , Pharmaceutical Industry , Prescription Drugs , Product Labels

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