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.…

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the alarm over the lack of detail on oversight/responsibility for remote vendors and a new“task log” in the FDA’s draft guidance on decentralized trials…

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…

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. Source:…

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