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Quarles & Brady LLP

March-In Rights Revisited: A New Era of Enforcement?

Quarles & Brady LLP on

On August 8, 2025, the U.S. Department of Commerce sent a letter to Harvard University—also shared publicly on the social media platform X—alleging that the university failed to comply with several provisions of the Bayh-Dole...more

DLA Piper

CRLs Made Public: What FDA’s New Policy Means For the Drug Industry

DLA Piper on

The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to...more

Perkins Coie

Caffeine Safety Legislation Introduced in Congress

Perkins Coie on

On March 31, 2025, Congress saw the reintroduction of H.R. 2511, the Sarah Katz Caffeine Safety Act. The bill would amend the Federal Food, Drug, and Cosmetic Act to establish new regulatory requirements for labeling the...more

Ballard Spahr LLP

COVID-19 Disclosures Bring Risks For Life Sciences Cos.

Ballard Spahr LLP on

COVID-19 has upended every corner of the financial markets, including the disclosure regime for publicly traded companies. Over the last few weeks, the number of disclosures relating to COVID-19 has exploded, with as many...more

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