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Upcoming events in the coming weeks include six FDA advisory committee meetings, the GMP Quality Management vSummit and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. 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the alarm over the lack of detail on oversight/responsibility for remote vendors and a new“task log” in the FDA’s draft guidance on decentralized trials (DCT).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
The number of Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) applications and certificates in the European Union (EU) increased significantly in a recent six-month period, signaling some success in addressing the need for recertification to meet the EU’s new regulations. Read More
AstraZeneca announced that it will pay $510 million to settle patent infringement lawsuits with Bristol Myers Squibb (BMS) and Ono Pharmaceutical involving cancer treatments using PD-1 and CTLA-4 methods. Read More
Risk management plans need to be continually updated as the design of a medical device or in vitro diagnostic evolves, said quality expert Dave Petrich in a July 19 webinar from FDAnews, a WCG company. Read More
Baxter Healthcare’s recall of 23,000 infusion pumps due to repeat upstream occlusion false alarms has been deemed class I by the FDA, the most serious type of recall as use of the device may cause injury or death. 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
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