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Savings to the federal government from minimum discounts will only accrue to $1.8 billion against Congressional Budget Office’s estimate of $3.7 billion in the upcoming implementation of the drug savings elements of the Inflation Reduction Act (IRA), according to a recent study published in the Journal of Managed Care + Specialty Pharmacy. Read More
Improving FDA advisory committee procedures and combatting misinformation are two important goals for FDA’s Chief Scientist Namandjé N. Bumpus who shared some insights from her first year of work during an informational “fireside chat” sponsored by the Alliance for a Stronger FDA on Wednesday. Read More
A new draft guidance focuses on obtaining tentative approval — granted for drugs that cannot be marketed in the U.S. because of existing patents or exclusivity — for various HIV treatment and prevention drugs intended for distribution outside the U.S. under the President’s Emergency Plan for AIDS Relief (PEPFAR). Read More
The FDA and the Drug Enforcement Agency (DEA) have asked manufacturers to confirm they are working to increase production of their allotted quota of ADHD drugs to help resolve shortages. Read More
Comments from numerous stakeholders have sounded the alarm over the lack of detail on oversight/responsibility for remote vendors and a new“task log” in the FDA’s draft guidance on decentralized trials (DCT). Read More
In the third revision to its guideline on good clinical practice, ICH E6, the International Council on Harmonisation (ICH) is proposing a full-scale restructuring of the document that has provided a global standard for sponsors, sites and investigators since 1996. In this blog post from Avoca, a WCG company, Karen Harvey, senior director of the Avoca Quality Consortium, outlines the changes in the new ICH draft guideline.Read More
The Modernizing and Ensuring PBM Accountability Act seeks to lower the cost of prescription drugs and provide taxpayer savings of approximately $1.7 billion. Read More
Industry trade group PhRMA has filed a complaint in district court alleging that Louisiana’s law requiring drugmakers to provide 340B drug discounts to contract pharmacies violates federal statute. Read More
Citius Pharmaceuticals’ BLA for its lymphoma drug Lymphir (denileukin diftitox) has hit a setback as the company has received a complete response letter (CRL) from the FDA requesting additional testing. Read More
The FDA and EMA have completed the first collaborative assessment of a critical oncology biologic, with the agencies reviewing and approving a proposal to add new manufacturing and quality control sites, the FDA announced on Friday. Read More
The collection, use and submission of patient experience data (PED) still requires significantly more FDA guidance, clarification and support, big-name sponsors told the agency in response to a request for information and comments on the subject. Read More