Eve Costopoulos
Loeb & Loeb LLP
Articles
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…
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…
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…
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…
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…
