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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Feature
09 Jan 2026
5 trends defining the next wave of life sciences M&A
As the market rebounds, five key trends are shaping the next wave of mergers and acquisitions in the life sciences industry. Continue Reading
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23 Dec 2025
The FDA approves the first GLP-1 weight loss pill
The FDA has approved the oral version of Novo Nordisk's popular injectable obesity drug Wegovy, making it the first GLP-1 pill cleared for weight loss. Continue Reading
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20 Apr 2020
NIH Ties Up with Top Pharma Companies for COVID-19 Drug Discovery
NIH and 16 other companies including J&J, Bristol Myers, GSK, and Roche, will develop a framework to advance clinical trials and boost COVID-19 drug discovery. Continue Reading
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16 Apr 2020
FDA Approves Selumetinib for Rare Pediatric Neurofibromatosis
Other recent FDA approvals include a generic albuterol inhaler, a blood purification device for COVID-19, and emergency use of N95 mask decontaminators. Continue Reading
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16 Mar 2020
FDA Authorizes Additional COVID-19 Testing in New York
Last week, the FDA took two significant steps to address the outbreak by giving New York COVID-19 testing flexibility. Continue Reading
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10 Mar 2020
Gene Therapy, Regenerative Medicine Markets Booming Worldwide
Gene therapy, cell therapy, and other regenerative medicines raised millions in 2019, and experts expect dollars to increase as adoption soars. Continue Reading
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09 Mar 2020
FDA Approves First Generic Drug Version of Daraprim
To increase patient access and boost market competition, the FDA approved the first generic drug version of the drug at the center of Martin Shkreli’s drug price gouging case. Continue Reading
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05 Mar 2020
Sanofi to Pay $11.85M to Resolve Medicare Fraud Allegations
The settlement will put to rest accusations that Sanofi paid kickbacks to patients in an alleged Medicare scheme fraud involving its charitable foundation, The Assistance Fund. Continue Reading
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28 Feb 2020
FDA Boosts Affordable Access to Insulin and Biological Products
The FDA’s new finalized rule will increase patient access to insulin products and other biological products, provide resources, and potentially lower drug prices. Continue Reading
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27 Feb 2020
Esperion Earns FDA Approval for Cholesterol Lowering Drug Nexletol
The FDA approval is the first in nearly 20 years for an oral, once-daily, non-statin LDL-cholesterol lowering drug for patient who cannot tolerate statin pills. Continue Reading
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13 Feb 2020
Congress’ Think Tank Digs Into Drug Patenting Practices
The Congressional Research Service reports on drug patenting practices as these “take place against a backdrop of a broader public policy debate over drug pricing.” Continue Reading
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12 Feb 2020
Industry Backs FDA Guidance on Patient-Focused Drug Development
With the forthcoming FDA guidance on patient-focused drug development, BIO and PhRMA argued for clarity on what patient experience data informs FDA decision-making. Continue Reading
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07 Feb 2020
CMS Moves to Foster Access to Generics, Biosimilars in New Rule
The administration is proposing to increase Medicare Part D drug pricing transparency via requirements to create more competition against specialty drugs. Continue Reading
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03 Feb 2020
FDA Breaks Down Barriers to Prioritizing Generic Drug Approvals
An update to the US Food and Drug Administration's policy on prioritization of generic drug applications enables the agency to prioritize submissions more likely to receive approval. 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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News
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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News
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