Newsletters

06.26.24

Energy and Commerce Chair Releases Framework with Recommendations to Overhaul NIH

On June 14, House Energy and Commerce Committee (E&C) Chair Cathy McMorris Rodgers published a “framework for discussion” proposing reforms to the National Institutes of Health (NIH).


06.05.24

Laboratory Association Sues FDA Over its Recent Laboratory-Developed Test Final Rule

On May 29, the American Clinical Laboratory Association (ACLA) sued the Food and Drug Administration (FDA) in an effort to vacate its recent final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests


05.23.24

Achieving a High Performance, Diverse Accrual, Clinical Trial Program in an Academic Health System

The United States occupies a leadership position in clinical advancements, in terms of pharmaceuticals, medical devices, innovative care processes and interventional techniques.


05.06.24

FDA Finalizes Rule to Phase Out Enforcement Discretion of Laboratory-Developed Tests

On April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), subjecting them to the same enforcement approach as other in vitro diagnostic (IVD) products.


03.25.24

Congress Revisits Longstanding Debate Over FDA Regulation of Lab-Developed Tests

On March 21, 2024, the Health Subcommittee of the House Energy & Commerce Committee held a hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.”


03.03.24

February 29, 2024: The “Rarest Day of the Year”

Rare Disease Day took place on February 29, 2024. Created in 2008, Rare Disease Day is observed on the “rarest day of the year”—February 29 in leap years (February 28 in non-leap years)—as a way to galvanize the global rare disease community around the goal of achieving ...


02.27.24

The FDA and the Future of AI Oversight

In January 2024, the U.S. Government Accountability Office (GAO) issued a report highlighting current obstacles to the U.S. Food and Drug Administration’s (FDA) timely and effective regulation of artificial intelligence (AI) and machine learning (ML) in medical devices and other emerging ...


01.29.24

Lykos MDMA Submission Series A

On December 11, 2023, following positive results from two published Phase 3 studies, MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the Federal Drug Administration (FDA) for an investigational MDMA-assisted therapy for persons suffering from post-traumatic ...


01.22.24

FDA Approves Florida’s Application to Import Drugs from Canada

On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years.


12.20.23

Supreme Court Will Hear Medication Abortion Case; Three States Ask to Intervene in District Court

On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al. (AHM v. FDA), marking the Court’s first return to the abortion debate since overturning ...