Matthew Piscitelli

Foley Hoag LLP

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U.S. Department of Commerce Investigates Possible Tariffs on Pharmaceuticals: Forecasting the Impact and an Opportunity to Comment

I. Key Takeaways - - The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more

4/18/2025 / Biologics , Comment Period , Drug Pricing , Food and Drug Administration (FDA) , Imports , Medical Devices , National Security , Pharmaceutical Industry , Prescription Drugs , Supply Chain , Tariffs , Trade Expansion Act of 1962 , Trade Relations , U.S. Commerce Department

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

10/3/2023 / CDRH , Clinical Laboratory Testing , Comment Period , Food and Drug Administration (FDA) , Healthcare , Manufacturers , Medical Devices , Proposed Rules , Regulatory Requirements

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

9/26/2023 / Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Healthcare Reform , Labeling , Pharmaceutical Industry , Prescription Drugs , Public Comment , Regulatory Requirements , Software

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