51ÁÔÆæ

The application date of May 26, 2022 for the EU In Vitro Diagnostic Medical Devices Regulation (2017/746), commonly referred to as IVDR, has come and gone. IVDR has created challenges...

The escalating challenges in pharmaceutical innovation include high costs and inefficiencies in drug development, frequently resulting in late-stage failures. To combat these issues, the adoption of Bayesian methodologies is recommended,...

Design Transfer helps manufacturers to reduce business risks during the medical device design process. It ensures the company produces the right product with the right process and at the right...

In this episode of 51ÁÔÆæ Radio®, host Brandon Miller, Steve Lynn, and Susan Schniepp explore what is happening in the Pharmaceutical industry in 2023 and provide you with insight on...

The US Food and Drug Administration (FDA) recently published finalized guidance for regulatory approval in the Cosmetics industry. This latest agency publication introduces new methodologies for good manufacturing practices that...

The U.S. Food and Drug Administration (FDA) conducts on-site investigations for organizations that manufacture and package drugs to protect patient safety and maintain a high-quality standard in the life science...