Phillip V. DeFedele

Continued Efforts To Onshore Pharmaceutical Manufacturing: FDA Announces New FDA PreCheck Program

FDA Issues New Guidance On Current Good Manufacturing Practices For Drugs

When APA Claims Accrue Under Corner Post: Implications For The Life Sciences Industry

What You Should Know About The FDA's New Final Rule On LDTs

FDA Intends To Regulate Many Clinical Labs As Medical Device Manufacturers: What You Need To Know About The Laboratory Developed Test Final Rule

EXPERT INSIGHTS—FDA Started A Process To 'Downclassify' Most High-Risk IVD Types: Here Is Why, (Mar 5, 2024)

FDA Started A Process To "Downclassify" Most High-Risk IVD Types: Here Is Why

FDA Proposes To Actively Regulate Laboratory-Developed Tests After Years Of Enforcement Discretion

FDA Releases Significantly Revised Final Clinical Decision Support Software Guidance And Related Changes

Medical Devices & Consumer Health Products 2022

Harmonisation Of International Rules On Medical Device Quality Management Systems

Medical Devices & Consumer Health Products 2021: Trends & Developments

White House Details Supply Chain Security And Resiliency Plans: What Pharmaceutical Manufacturers Need To Know

HHS Finalizes New Protections Under The Stark Law For Value-Based Arrangements And Makes Other Critical Revisions And Clarifications To The Regulations That Physicians And Designated Health Service Entities Must Understand

Final FDA Guidance Reinforces Increased Focus On Diversity And Inclusion In Clinical Development

Guide To The Trump Administration's Drug Importation Final Rule And Guidance

Building Upon The Promise Of 21st Century Cures: The Cures 2.0 Concept Paper

Update On Medical Products Shortage Reporting: What Manufacturers Need To Know Regarding FDA's New Reporting Guidance And Expanded Reporting Under The CARES Act

A New Private Right Of Action Is Created For Refusals To Provide Drugs And Biologics To Certain Product Developers