Posted by LLS Health Technical Team | 03/17/2023
The FDA 505(b)(2) regulatory pathway for drug approval, which allows applicants to use existing safety data as evidence, continues to grow in popularity.
Posted by LLS Health Technical Team | 01/31/2022
In this post Lubrizol Life Science Health explores the regulatory requirements governing excipient safety for the United States as an example of best practice to help formulators understand how to select the most appropriate carbomer for their needs.
Posted by LLS Health Technical Team | 10/25/2021
The EU Medical Device Regulation 2017/745 (MDR) that went into effect May 26, 2021, presents a number of challenges for medical device manufacturers, especially makers of implantable and invasive devices.
Posted by LLS Health Technical Team | 10/13/2021
The safety of a medical device is of utmost concern and importance at all times during its development, manufacturing, regulatory submission and use. One critical step in establishing the safety of a device is to evaluate how the device interacts with the body. Device makers’ materials suppliers may be helpful in conducting the evaluations at both the material and device levels.
Posted by LLS Health Technical Team | 05/04/2020
The current regulatory landscape, or lack of an independent excipient approval pathway, may be limiting the entrance of new excipients in the market and, subsequently, new drug products. We sat down with the Director of Regulatory Strategy and Policy for Lubrizol Life Science Health (LLS Health), Meera Raghuram, to discuss the importance of novel excipients and recent actions taken by the FDA.
