Medical policy and regulation
Medical policy and regulation in healthcare ensure the safety, efficacy and quality of medical treatments and services by setting standards and guidelines for medical practices, drug development and healthcare delivery. Continuous updates and oversight in medical policy and regulation help guide clinical innovation and refine current approaches to healthcare.
Top Stories
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News
07 Nov 2025
CMMI to launch model to lower Medicaid drug spending
Under the model, set to start next year, the CMS will negotiate lower prices for Medicaid programs linked to those paid in select other countries with participating pharmaceutical manufacturers. Continue Reading
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07 Nov 2025
FDA expands the National Priority Voucher program to oral GLP-1s
The FDA's second wave of National Priority Voucher recipients includes Novo Nordisk and Eli Lilly's oral GLP-1s, expanding the list to 15 products. Continue Reading
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03 Feb 2020
FDA Aims to Bolster Gene Therapy Development with New Guidance
With more than 900 INDs for gene therapies currently in development, a new deluge of FDA final and draft guidances aim to accelerate gene therapy development. Continue Reading
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30 Jan 2020
FTC, NY Sue to Ban Martin Shkreli From Pharmaceutical Industry
FTC and the state of New York filed a lawsuit seeking to permanently ban Martin Shkreli and another former Vyera Pharmaceuticals executive from the pharmaceutical industry over Daraprim’s price. Continue Reading
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24 Jan 2020
Improving Vaccination Efforts Requires Renewed Commitment
Authors of a recent op-ed call for a renewed commitment to eliminating known diseases through robust vaccination efforts. Continue Reading
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17 Jan 2020
FDA Proposes Policies for Pediatric Studies
FDA addressed a new pediatric requirement on submissions for pediatric studies. Continue Reading
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17 Jan 2020
Study: FDA Should Simplify Drug Approval Programs
Researchers claim regulatory innovations have resulted in drug approvals based on weaker data, and a former top FDA official has suggestions. Continue Reading
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15 Jan 2020
Industry Supports FDA’s Reorganization of Office of New Drugs
Industry feedback sought to inform the direction of FDA reorganization efforts for its Office of New Drugs. Continue Reading
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13 Jan 2020
CA Proposes Single Market for Drug Pricing, Manufacturing Hub
California is looking to establish a single market for drug pricing within the state and a new contracting program for generic drugs. Continue Reading
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09 Jan 2020
Drug Price Hikes Undeterred Despite Legislative Proposals
Hundreds of drug prices have increased to begin the year against a backdrop of Congressional efforts to curb spending on prescription drugs. Continue Reading
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16 Dec 2019
Senate Confirms Hahn as FDA Commissioner in Bipartisan Vote
Stephen Hahn, MD, received a 72-18 vote into his new role as FDA commissioner. Continue Reading
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20 Nov 2019
How Could Drug Price Proposals Impact Pharma Company Profits?
Proposals to curb drug price increases will limit but not eliminate the profitability of pharmaceutical companies. Continue Reading
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15 Nov 2019
Exploring International Reference Pricing for Pharmaceuticals
Policymakers are considering an international reference pricing model to reduce prescription drug costs, but will this model succeed in the US? Continue Reading