FDA is modernizing and streamlining the regulatory processes for product development. This article examines FDA's proposed rule to exempt the production of Phase 1 clinical trial materials from the GMP regulations and questions whether this proposed exemption will truly improve public health and promote faster and more predictable access to new medicines.
Modernizing, Managing, and Complying with Regulatory Advances in Science
November 17th 2016Change, while scary, is a necessity. Opportunities for increased efficiency, higher profitability, and the ability for an organization to maintain a competitive advantage necessitate the need for change. Correctly adopting new liquid chromatography (LC) technology can be very challenging, however, when done correctly, modern LC technology can give a laboratory the ability to simplify method transfer across a diversity of analytical LC platforms at all of its facilities.