K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Texas Attorney General Ken Paxton recently announced that his office is investigating some of the country’s most ubiquitous home brands — including Colgate-Palmolive, Proctor & Gamble, and General Mills — for allegedly...more
Emergency Use Authorizations will play a role as the pandemic eases, but a transition to ordinary course approvals is underway. As long as the COVID-related emergency is deemed to exist, fast-tracked FDA regulatory...more
On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the...more
On July 10, 2019, President Trump issued an Executive Order on Advancing American Kidney Health (the EO). Executive orders are issued under the authority of the Constitution, Article II, Sections 1 and 3, requiring that the...more