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Latest Posts › Food and Drug Administration (FDA)

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Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers

I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more

9/9/2021 / Comment Period , Cyber Attacks , Cybersecurity , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Software , Public Comment , Risk Mitigation

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect...more

1/7/2021 / Biosimilars , Food and Drug Administration (FDA) , Generic Drugs , Labeling , Life Sciences , New Amendments , Orphan Drugs , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

FDA Requests Comment on Term “Natural” in Food Labeling

On November 10, 2015, the FDA announced that it will be soliciting public comments on the use of the term “natural” in food labeling. The comment period will open on November 12, 2015 and is expected to close on February 10,...more

11/11/2015 / Biotechnology , Comment Period , Food and Drug Administration (FDA) , Food Labeling , Natural Products

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