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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
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. 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
Friday, Biogen announced that it was planning to acquire Reata for approximately $7.3 billion, while Alexion, AstraZeneca’s rare disease subsidiary, announced that it had entered a purchase and license agreement for a portfolio of preclinical gene therapy programs and technologies from Pfizer. Read More
The Senate Finance Committee has advanced a bill seeking to reform pharmacy benefit managers (PBMs) by prohibiting them from deriving compensation for Medicare Part D-covered drugs based on the drug’s list price, among other proposals. Read More
HHS announced plans to issue several FDA-related proposed and final rules in the coming year in its semiannual inventory of rulemaking actions. Read More
Over the past week, the FDA issued final guidance for deoxyribonucleic acid (DNA) reactive impurities in pharmaceuticals, assessing biosimilar user fees, hydrogen peroxide-based contact lens products and CDER’s program for the recognition of voluntary consensus standards guidance on medical device development tools. The FDA 2024 user fees were also announced. Read More