Law

Since the year began, we have attempted to divine the new administration’s approach to regulating human cell and tissue products (“HCT/Ps”).[1] What we have found is …

In late September, the U.S. Food & Drug Administration (“FDA”) issued three draft guidances related to cell and gene therapy (“CGT”) products: (1) Innovative Designs for …

On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued numerous untitled letters as part of the agency’s …

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Late yesterday, FDA issued a press release warning that it would be sending “thousands of letters warning pharmaceutical companies to remove misleading ads and issue approximately …

On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim …

ICYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human …

In Eye Therapeutics, LLC, v. Slayback Pharma, LLC., Appeal no. 2023-2173, (Fed. Cir., June 30, 2025), a panel of Judges Scarisi, Stoll and Tramto reversed a …

In an interesting and somewhat unexpected turnabout over the last six months, FDA has pivoted its focus from regulating industry’s use of artificial intelligence (“AI”) to …

Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus …