Day: June 20, 2024

The FDA has created new rules specifically for medical gases to improve how they are labeled, manufactured, certified, and reported for safety. These rules aim to address the unique characteristics of medical gases and ensure that they meet safety and quality standards.  Under the new rules, manufacturers of medical gases will be required to follow … Read more

The FDA has set rules under the GDUFA III commitment for how to handle a facility’s readiness for inspection for ANDA applications, which affects the goal date for an application. A new FDA Guidance Document released this week provides a simpler breakdown of these rules.  Applicants must list their manufacturing sites and their contact info … Read more