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…

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…

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…

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. Source: Drug…

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.…

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily

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…

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…

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…

This week, three medical devices used for cardiac issues were deemed class I by the FDA, the most serious type of recall, as use of the device may cause serious…