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U.S. implements new export controls on toxins, plant pathogens and biological equipment

The United States Department of Commerce’s Bureau of Industry and Security has issued regulations to amend the Export Administration Regulations to implement changes to controls of...


FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act...


O.K. Corral: FDA sets stage to appeal California Stem Cell Treatment Center decision

Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should...

Hogan Lovells Podcasts

"Thanks... Good Talk" Shortcast

Ivan Zapien focuses his shortcast on the issues, people, and culture that help shape Washington, D.C.


FTC’s proposed ban of employer non-competes: Are non-profits exempt?

The Federal Trade Commission’s (FTC’s) January 5, 2023 Notice of Proposed Rulemaking (NPRM) for the Non-Compete Clause Rule, which would ban nearly all post-employment...


Homeopathic drug product makers warned to follow FDA premarket and GMP rules

Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing...


Can sterile drug manufacturers implement EU GMP Annex 1 requirements before August?

In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP)...


FTC seeks to reinvigorate enforcement of Robinson-Patman Act

The US Federal Trade Commission’s (“FTC”) reported investigations of Coca-Cola Co. and PepsiCo. Inc. for price discrimination are a significant step toward the...


U.S. Congress embraces FDA’s approach to clinical trial diversity in new Omnibus legislation

In the waning days of 2022, Congress passed the omnibus spending legislation to provide funding for the federal government through September 2023. The legislation contains numerous reforms...

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