Matthew Piscitelli

Matthew Piscitelli

Foley Hoag LLP

Contact
View Bio
RSS

Latest Posts › Manufacturers

Share:

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

8/11/2025  /  Department of Health and Human Services (HHS) , Executive Orders , Food and Drug Administration (FDA) , Manufacturers , National Security , New Guidance , Pharmaceutical Industry , Public Health , Regulatory Reform , Supply Chain

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
2 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide