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Court Holds AKS Violation Does Not Require ‘Corrupt Intent’ in Pfizer Medicare Patient Assistance Lawsuit

USA - October 11 2021 A New York federal court rejected Pfizer’s request for a declaratory judgment that its proposed copay support programs do not violate the federal…

Alison Mulry Babitz, Scott S. Liebman

PhRMA Announces Revisions to the Code of Interactions with Health Care Professionals, Effective Jan. 1, 2022

USA - August 16 2021 Pharmaceutical Research and Manufacturers of America (PhRMA) released on Aug. 6 revisions to the Code of Interactions with Health Care Professionals…

Scott S. Liebman

FDA Regulatory and Compliance Monthly Recap - February 2021

USA - February 7 2021 The FDA updated its guidance concerning pharmacists and outsourcing facilities temporarily compounding alcohol-based sanitizer products. The guidance…

Scott S. Liebman

FDA Regulatory & Compliance 2020 Year in Review

USA - January 24 2021 The COVID-19 pandemic in the United States and around the globe impacted local, state, and federal public health policies, activities and resources…

James N. Czaban, Scott S. Liebman

FDA Regulatory and Compliance Monthly Recap - January 2021

USA - January 7 2021 The FDA issued a guidance providing recommendations for resuming or initiating bioequivalence (BE) studies for generic drugs during the ongoing…

Scott S. Liebman