FDA Seeks Input On Development, Evaluation Of At-Home Devices

FDA’s device center is seeking public feedback on how to better meet the needs of patients who use medical devices and diagnostics at home and in other non-traditional settings, saying the effort is part of its health equity mission. In a notice sent out Thursday (June 1) , FDA says the agency is committed to ensuring patients can access medical devices that are safe and effective when used outside of a traditional care setting. “Access to devices outside a clinical...
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FDA Seeks Input On Development, Evaluation Of At-Home Devices

FDA’s device center is seeking public feedback on how to better meet the needs of patients who use medical devices and diagnostics at home and in other non-traditional settings, saying the effort is part of its health equity mission. In a notice sent out Thursday (June 1) , FDA says the agency is committed to ensuring patients can access medical devices that are safe and effective when used outside of a traditional care setting. “Access to devices outside a clinical...
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Buprenorphine Access Varies Widely By State, Chain Pharmacies

Despite recent moves by the Biden administration and Congress to facilitate access to the opioid use disorder treatment buprenorphine, including through telehealth, patients are still facing barriers to getting their prescriptions filled at local pharmacies, according to a new study released in JAMA Open Network. Dispensing regulations imposed by federal and state governments may be contributing to lack of access at retail pharmacies, the study says. The Drug Enforcement Administration recently extended telehealth prescribing for the OUD treatment for the...
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Debt Ceiling Deal Threatens FDA Funding: Expert Analysis

The debt ceiling legislation headed to the president’s desk could stress FDA’s budget, an FDA funding expert warned in a blog post analyzing the high-impact deal. The expert wrote that the deal’s non-defense federal funding cap makes it harder for domestic discretionary programs, like FDA’s budget, to nab funding increases and warns that existing funds for some agencies could be threatened. “This is never a good situation for agencies whose mission and responsibilities keep expanding each year, as is the...
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Duke Floats Ways To Collect Alzheimer’s Data Without Cutting Drug Access

As CMS cements its plan to hinge broad coverage of Alzheimer’s anti-amyloid drugs that are fully approved by FDA on patients participating in registries, prominent health policy researchers are warning CMS to tread carefully because the registry requirement could cut off treatments for patients whose providers have limited capacity to collect data and may not be able to safely administer the drugs. The researchers lay out ways CMS could still collect post-market data while maximizing access to treatments. Duke Margolis...
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Duke Floats Ways To Collect Alzheimer’s Data Without Cutting Drug Access

As CMS cements its plan to hinge broad coverage of Alzheimer’s anti-amyloid drugs that are fully approved by FDA on patients participating in registries, prominent health policy researchers are warning CMS to tread carefully because the registry requirement could cut off treatments for patients whose providers have limited capacity to collect data and may not be able to safely administer the drugs. The researchers lay out ways CMS could still collect post-market data while maximizing access to treatments. Duke Margolis...
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IDP Issue: 
Inside Drug Pricing - 06/05/2023
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Vol. 6, No. 23
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