FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies ...
The US Food and Drug Administration (FDA) has issued warning letters to two researchers for failing to meet good clinical practice (GCP) requirements and for not complying with their own trial ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to ...
Industry groups and legal experts want the US Food and Drug Administration (FDA) to make significant revisions to a proposed guidance on how pharmaceutical manufacturers should address Form 483 ...
Australia’s Therapeutic Goods Administration (TGA) has released guidance on manufacturing, supplying, and advertising ...
The Pharmaceutical Research and Manufacturers of America (PhRMA) said the US Food and Drug Administration’s (FDA) recent ...
Join a RAPS San Francisco networking and recruitment series across multiple in-person events. Meet regulatory professionals, connect with chapter leaders, and learn about ambassador and leadership ...
The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results