RAPS is looking for authors for the August 2023 issue of Regulatory Focus, which publishes monthly in-depth, peer-reviewed content on emerging issues in the global regulatory landscape.
The issue will focus on all aspects of Chemistry, Manufacturing, and Controls (CMC). Article topics could fall within the following broad topic-areas:
· Understanding the impact of PDUFA VII
· Analyzing emerging technologies for cell & gene therapy
· Implementing of ICH Q12, Q13, Q14
· Development and implementation for global change control
· Understanding the Drug Supply Chain Security Act (DCSCA)
Read the Guidelines for Authors to learn more about Regulatory Focus evidence-based articles and how to submit an article. For more information, email rmatthews@raps.org