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Drugs for serious or life-threatening diseases can receive expedited U.S. Food and Drug Administration (FDA) review, allowing patients to receive faster access to promising new treatments. Under the expedited review pathway of accelerated approval, drugs can be FDA-approved based on surrogate markers or proxy measures such as changes in imaging or lab tests that are “reasonably likely” to predict whether patients improve in how they feel, function, or survive.
- June 13, 2024Source: Nature
Researchers are calling on the US Food and Drug Administration (FDA) to be more transparent in how it incorporates recommendations from independent scientists on its advisory panels when it approves drugs or makes other key decisions.
- May 28, 2024
Surrogate markers of disease outcome aimed at speeding clinical trials are routinely accepted by the FDA for drug approvals, but most lack the requisite evidence.
- April 29, 2024
Researchers estimated the costs to produce a range of diabetes medicines, including insulin, SGLT2 inhibitors, and GLP-1 agonists. Their findings highlight market prices that are far above those costs.
- April 24, 2024
A recent study published in Journal of the American Medical Association (JAMA) Network Open found that key diabetes medicines can likely be manufactured at costs far below their current market prices. The economic evaluation, led by Yale postdoctoral associate Melissa Barber, PhD in conjunction with collaborators from Doctors Without Borders (Médecins Sans Frontières (MSF)), calculated the manufacturing costs for insulins, sodium-glucose cotransporter 2 inhibitors (SGLT2Is), and glucagon-like peptide 1 agonists (GLP1As) – all widely used diabetes medicines.
- April 03, 2024
A recent collaborative study conducted by Yale researchers sought to apply these methods towards developing a framework for measuring equitable readmissions to the hospital, and to identify hospitals that have equitable rates of readmission.
- April 01, 2024
Yale faculty and trainees will present clinical research at the upcoming American College of Cardiology Scientific Meeting.
- December 14, 2023
The Department of Internal Medicine is pleased to welcome the following new staff, faculty, postdoctoral/postgraduate associates, and postdoctoral fellows who joined the team in November 2023.
- October 12, 2023
The Department of Internal Medicine is pleased to welcome the following new staff, faculty, postdoctoral/postgraduate associates, and postdoctoral/postgraduate fellows who joined the team in September 2023.
- October 05, 2023
An FDA advisory committee found that an OTC decongestant, phenylephrine, works no better than a placebo at relieving congestion. Yale researchers discuss how drugs with insufficient evidence make it to market.