Background -
On April 7, 2025, the U.S. District Court for the Northern District of Texas vacated key provisions of CMS’s final rule establishing minimum staffing requirements for long-term care facilities. The rule would...more
On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over laboratory-developed...more
Why Do Clinical Trials?
Clinical trials are an important — and government-required — step on the way from an idea to a commercial medicinal product. All new pharmaceutical and biological products and most generic...more
On May 14, 2020, the U.S. Food and Drug Administration (FDA) updated its FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency – Guidance for Industry, Investigators, and...more