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Final Drug Pricing DTC Advertising Rule to Take Effect July 9 - But Faces Challenges from Pharmaceutical Companies

USA - June 27 2019 On May 10, 2019, CMS issued the final rule, which is similar to the proposed version and includes a template for price disclosure: “The list price…

David Abernethy

§ 510(k) Safety and Effectiveness - A Changing Landscape for Punitive Damages?

USA - October 23 2018 The Central District of California recently issued an opinion that breathes new life into the argument that the § 510(k) substantial equivalence…

Matthew P. Smith