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President Biden issues sweeping Executive Order to promote competition

USA - July 12 2021 On 9 July 2021 President Biden signed a far-reaching executive order intended to promote competition in the American economy. The order targets…

Logan M. Breed, Arjun Garg, Chuck Loughlin, Leigh L. Oliver, Edith Ramirez, Kevin Sheys.

Biden Administration Releases First 100-Day Review, Spurring Immediate Actions for US Supply Chains

USA - June 11 2021 Pursuant to Executive Order 14017, issued by President Biden on 24 February 2021, a federal government task force examined the vulnerabilities in…

Lance D. Bultena, Cayla D. Ebert, Craig Lewis, Chandri Navarro, Kelly Ann Shaw, Joy Sturm, Mary Anne Sullivan.

In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn

USA - June 1 2021 On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug…

Robert Church, James R. Johnson, Philip Katz.

First company receives FDA violation notice for ClinicalTrials.gov submission omission

USA - April 29 2021 On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required…

Robert Church, Heidi Gertner, Bert Lao, Blake E. Wilson.

FDA ups OTC monograph facility fees 45% for FY 2021, with exemption for some hand sanitizer makers

USA - March 26 2021 In today’s Federal Register, the U.S. Food and Drug Administration (FDA) updated and reissued the rates for over-the-counter (OTC) monograph drug user…

Heidi Gertner.