Over the coming days, Inside Health Policy will roll out a series of articles based on conversations with key stakeholders regarding their impressions of Gottlieb’s progress thus far, and where they see him taking the agency on key issues, including: off-label promotion, regulatory reform and drug pricing.
The National Institutes of Health (NIH) will conduct a phase III HIV vaccine efficacy trial at multiple clinical research sites in North America, South America and Europe, the agency announced Monday (July 15).
FDA lays out how to establish the safety and efficacy of birth control medicines, including oral contraceptives, long-acting injectables and intrauterine systems (IUSs), in draft guidance published Thursday (July 11).
A Maryland court has ordered all e-cigarette makers to submit premarket applications for their products to FDA within 10 months, by May 2020, or be subject to FDA enforcement actions.
Drug companies and consumer advocates applauded the United Kingdom health department’s decision to test a first-of-its-kind subscription-style model that pays drug companies upfront for new antibiotics based on their usefulness to the U.K’s single-payer health system.
SAN DIEGO -- FDA officials recently emphasized that drug pricing, while an important topic, is one that they generally can’t address as part of the regulatory process due to statutory restrictions.
A bipartisan group of senators, including Sens. Chuck Grassley (R-IA) and Dianne Feinstein (D-CA), has introduced a bill that aims to encourage scientific and medical research on marijuana in part by streamlining development of FDA-approved drugs that use cannabidiol (CBD) and marijuana.
President Donald Trump calls for steps to encourage the development of wearable or implantable artificial kidneys as part of an executive order he unveiled Wednesday (July 10) to improve American kidney health.
FDA took steps Wednesday (July 10) to reduce waiting periods in the generic drug approval process by encouraging industry to propose revisions to United States Pharmacopeia (USP) monographs while applications are pending agency approval.
FDA updated guidance on Tuesday (July 9) that explains how drug and biologic sponsors should submit modifications to risk mitigation plans, but did not give into a number of suggestions from both the brand and generic drug industries.
FDA is expediting review of all generic drug applications for overdose-reversal drugs, including naloxone nasal spray, injection and auto-injector, and nalmefene injection, the agency announced Monday (July 8).
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