December 9, 2025

1:00 pm ET - 3:30 pm ET

Location:

The HALT Fentanyl Act and its effect on research involving controlled substances; Declaration of Taipei

The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.

This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.

Topics: (1) The HALT Fentanyl Act and its effect on research involving controlled substances; (2) Declaration of Taipei

1. HALT Fentanyl Act and Research.  On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances Act (“CSA”), and much of the political commentary and media attention related to the legislation have focused on this specific provision and its potential impact on the nation’s fentanyl crisis.  However, the HALT Fentanyl Act also contains numerous significant reforms related to research activities with controlled substances, including provisions streamlining the process for conducting research with any Schedule I controlled substance. We will discuss takeaways from the HALT Fentanyl Act that drug developers, academic medical centers, research institutions, and others involved in nonclinical or clinical research with controlled substances should consider for their ongoing and future research activities.

2. A meeting is taking place in December 2025 in Taipei, Taiwan to discuss revisions to the Declaration of Taipei.  Barbara Bierer is attending this meeting and will lead a discussion of key changes to the Declaration that were discussed at the meeting.

For more information, please email at MRCT@BWH.HARVARD.EDU

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November 22, 2022

Research, Development, & Regulatory Roundtable (R3) ›

Research, Development, and Regulatory Roundtable (R3)