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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
Last month, the Russian government passed a decree (the Decree) amending the rules on state regulation of ceiling prices for drugs included into the Vital and Essential Drugs List, which is approved annually.
The US Food and Drug Administration (FDA) issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update.
Law360 published an article on August 18, 2018, by Morgan Lewis life sciences lawyers that discusses the FDA’s plans to advance biosimilar products.
In an attempt to minimize perceived obstacles to generic drug market entry, the FDA issued two draft guidance documents on May 31, 2018, related to shared system risk evaluation and mitigation strategies (REMS), providing the industry with insight into a previously underdefined area of FDA regulation.