Newsletter - June 20, 2024
FDA Updates cGMP Rules for Medical Gases
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...Read More
Ensure GMP Sites Are Ready for FDA Audits to Avoid Delay in ANDA Approval
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...Read More
FDA Updates cGMP Rules for Medical Gases
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...Read More
Ensure GMP Sites Are Ready for FDA Audits to Avoid Delay in ANDA Approval
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...Read More
