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DEA has done little to reduce the appearance of agency capture by the Opioid Treatment Program (OTP) industry, while FDA was years behind the evidence in approving over-the-counter naloxone.
Improves clinical trials by requiring the Food and Drug Administration (FDA) to issue guidance on the use of digital health technologies in clinical trials; decentralized clinical trials; and other innovative designs to support development of new drugs. Senators Murray and Burr expect the legislation to progress this year.
Opioid Use Disorder Treatment to Federal Bureau of Prisons The collaboration will enable patients to access Bicycle Health’s evidence-based, life-saving clinical care model delivering virtual Medication for Opioid Use Disorder (MOUD) services to individuals living in the FBOP’s Residential Reentry Centers (RRC).
The Substance Abuse and Mental HealthServicesAdministration recently released a free mobile app for clinicians called MATx. The Agency for Healthcare Research and Quality is launching a three-year $19M initiative focusing on mobile apps and telehealth aids for rural physicians in efforts to treat opioid addiction.
Prior to the federal COVID-19 Public Health Emergency (PHE), to initiate treatment with buprenorphine at an OTP, a practitioner needed to perform a complete in-person physical evaluation. The covered benefit includes MAT for patients with OUD, a leading treatment modality that combines prescribing FDA-approved medication (e.g.,
Should the final rules limit the issuance of prescriptions of controlled medications to the FDA-approved indications contained in the FDA-approved labeling for those medications? DEA has specifically requested feedback on whether it should limit telemedicine prescribing to only the drug’s FDA-approved indications. 21 U.S.C. §
Funding for the Centers for Medicare and Medicaid Services will increase by $100 million, the National Institutes of Health will receive an additional $2.5 Those requirements will take effect 90 days after the bill is enacted.
Department of Health and Human Services (HHS), through the Substance Abuse and Mental HealthServicesAdministration (SAMHSA), awarded nearly $1.5 – Releasing New Guidance to Support and Facilitate Greater Access to FDA-approved naloxone products. What You Should Know: – The U.S
Section 3602 of the Act requires FDA to issue new guidance or update existing guidance specifying the form and content of diversity action plans for enrollment, disaggregated by age, group, sex, and racial and ethnic demographic characteristics of clinically relevant populations.
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