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Coverage
On the FDA’s behalf, the Reagan-Udall Foundation has held roundtables with industry members to share insights, identify and prioritize key issues, and explore implementation strategies.
The FDA noted that a Reagan-Udall Foundation public meeting in the spring of 2023 — with FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA) — and a December 2023 meeting with FDA, SAMHSA, and the National Institute on Drug…
Additionally, the Reagan-Udall Foundation held a series of roundtables with industry members to share insights from those involved in implementation, identify and prioritize key issues, and explore implementation strategies.
Her sentiments echo concerns raised by the Rudd Center for Food Policy & Health at a public meeting hosted by The Reagan-Udall Foundation for FDA in November 2023.
“Our team has had over 185 meetings across industry sectors and answered over 400 questions through our technical assistance network. We also worked with the Reagan-Udall Foundation to meet with industry through a series of roundtables and the public…
We also received similar feedback through several meetings in which FDA participated, including a two-day public meeting with the Reagan-Udall Foundation for the FDA in May 2023 and two listening sessions led by the Substance Abuse and Mental Health…
In May 2023, the Reagan-Udall Foundation hosted a 2-day public meeting with FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA), entitled “Considerations for Buprenorphine Initiation and Maintenance Care.”
Earlier this year, Ultragenyx reached agreement with the Agency that CSF HS can be used as a surrogate endpoint for accelerated approval based on the body of data presented by the company, along with a consortium of academics and other industry sponsors…
Drs. Robert Califf and Marta Sokolowska underscore the distinctive advantages primary care providers can bring to positively impacting the lives of people with opioid use disorder, referencing the Foundation’s virtual public meeting exploring “…
In the fall of 2022, the Reagan-Udall Foundation—an independent organization established by Congress to advance the mission of the FDA—evaluated the CTP and identified several key areas for improvement. Released in December 2022, the report outlined 15…