Interest in the potential for psilocybin to be developed as a mental health treatment has continued to grow in recent months, due in part to recent activity by the U.S. Food and Drug Administration (FDA) and Drug Enforcement...more
The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation under 21 CFR 820....more
A federal appeals court recently upheld misdemeanor convictions of two former executives of Acclarent Inc, a medical device manufacturer, for commercially distributing an adulterated and misbranded medical device by...more
In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more
In January 2022, the U.S. Food and Drug Administration (FDA) released finalized guidance on premarket pathways for combination products.
While the guidance is not binding, it provides industry participants with valuable...more
On July 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for sample pooling of specimens when using the SARS-CoV-2 rRT-PCR diagnostic test from Quest Diagnostics....more
The next in our series of posts sharing key takeaways from panels at the Healthcare & Life Sciences Private Equity and Lending Conference is authored by our colleagues Brian King and Royce DuBiner, and Kathy Contratto of RSM...more