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
Orexo announced that it has received a complete response letter (CRL) from the FDA regarding its NDA for OX124, a high-dose naloxone rescue medication for opioid overdose. Source: Drug Industry…
Baxter International has issued an urgent medical device recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly as there is a risk of…
The FDA has issued new recommendations on pediatric drug trials, issuing a draft guidance on inflammatory bowel disease (IBD) drug development and a final guidance on extrapolating partial onset seizure…
Congressman Jack Bergman (R-Mich.) joined bipartisan lawmakers, veterans and post-traumatic stress disorder (PTSD) experts to highlight the need for FDA approval of midomafetamine (MDMA) -assisted therapy to address the treatment…
The FDA has opted to terminate CBER’s Allergenic Products Advisory Committee due to the expert group’s relative inactivity over the past few years, shifting its duties over to the Vaccines…
The FDA has issued final guidance on application fees for combination products, explaining that when a sponsor submits a single application for a combination product, the fee should be for…