As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws…

The FDA has issued a final guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balance studies, including deciding whether and when to conduct the study, designing…

Following a Form 483 inspection report that Jiangsu Hengrui Pharmaceuticals of China was found to be storing sterile injectable drugs bound for the US market on corroded metal racks which…

FDA has established a new Rare Disease Innovation Hub (the Hub) to leverage cross-agency expertise and spur the development of treatments for rare diseases, CDER Director Patrizia Cavazzoni and CBER…

The Mark Cuban Cost Plus Drug Company is offering a low-cost, imported penicillin product after being given temporary approval by the FDA to help ease the ongoing shortage of Pfizer’s…

This week, the FDA published final guidance on drugs for treatment of partial onset seizures, combination product user fees, radiolabeled mass balance study clinical pharmacology considerations. Draft guidance was issued…

Sterile drugmakers seeking to comply with new EU GMP guidelines introduced in August 2023 should consider an in-depth gap assessment in their facilities — working through the guidelines line by…

The FDA has sent an additional warning letter to China-based Jiangsu Shenli Medical Production for quality system violations for its enteral syringe products and expanded the company’s import alert to…

In this edition, we note the release of the EU’s highly anticipated AI Act, new reporting requirements for expected interruptions in the supply of medical devices or diagnostics and new…

The UK’s Prescription Medicines Code of Practice Authority (PMCPA) has dinged Novartis, Pfizer, Otsuka and Novo Nordisk for breaches of its code of practice. Source: Drug Industry Daily