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FDA Round Up – Q4 2023


New FDA guidance: Stimulant Use Disorders:  Developing Drugs for Treatment (Draft October 2023) – The purpose of this guidance is to provide Sponsors with recommendations on clinical development of drugs for the treatment of stimulant use disorders, including moderate to severe cocaine use disorder, treatment of moderate to severe methamphetamine use disorder, or treatment of moderate to severe prescription stimulant use disorder.  FDA notes that there is great heterogeneity in the individuals who meet the diagnostic criteria for stimulant use disorder and this issue poses significant challenges when designing clinical trials.  The guidance presents FDA’s current recommendations on early development considerations, patient populations (inclusion/exclusion criteria), measurements of drug use, endpoints, benefit-risk considerations, and labeling.  Because there are no FDA approved products for stimulant use disorders, FDA notes that many products in development may be eligible for breakthrough designation, fast track designation, priority review designation, and accelerated approval.  The guidance can be found here:

LDT proposed rule – on September 29,2023, the FDA announced the proposed rule (Medical Devices; Laboratory Developed Tests) which seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.  FDA is also proposing a policy for them to provide greater oversight of LDTs by phasing out enforcement discretion and regulating LTDs as medical devices.  The purpose of these proposals is to better assure the safety and effectiveness of IVDs offered as LDTs.  See here for an FDA webinar on the topic.

Dr. Janet Woodcock, Principal Deputy Commissioner, FDA retiring in early 2024 –

Dr. Wiley Chambers, Acting Director of the Office of Specialty Medicine – Division of Ophthalmology leaves FDA –

Timothy Stenzel, Chief of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health retires at the end of 2023 –

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