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Focus on Regulation

Tag Archives: exemption

European Medicines Agency’s clarification regarding re-testing exemption for imported advanced therapy medicinal products

1.            Introduction On 21 August 2019, the European Medicines Agency (EMA) published questions and answers regarding imported advanced therapy medicinal products (ATMP). The document focuses on the possibility of batch controls exemption for ATMP imported into the European Union from a third country. It provides guidance concerning grant of the exemption, data to be submitted

State Boards Seeking an Antitrust Pass? FTC Explains What They Need to Know

A Supreme Court decision from February ruled that state regulatory boards run by “a controlling number” of “active market participants” can qualify for an antitrust exemption only if they are “actively supervised” by the state. But the Court left the content of those key terms vague, leaving states to wonder about the degree of antitrust scrutiny their regulatory boards will face. The FTC staff last week issued guidance on how they believe the Supreme Court’s decision should be implemented.