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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.

FDA Regulatory and Compliance Monthly Recap - December 2020

USA - December 30 2020 FDA issues final guidance on complex innovative trial designs for drug, biologic sponsors The FDA issued a final guidance providing sponsors and…

Scott S. Liebman.

Biogen To Pay $22 Million To Settle DOJ Claims Alleging Copay Scheme

USA - December 24 2020 The U.S. Department of Justice reached a $22 million settlement with Biogen Inc. on Dec. 17 to end allegations that the pharmaceutical company…

Scott S. Liebman.