by Don McLean | Jun 27, 2019 | Blog
Pharmaceutical Industry News Roundup: June 2019 by Staff writer Each month, MMS shares key stories on the evolution of the pharmaceutical industry. Here is a selection of top stories to keep an eye on: FDA ‘open for business’ in considering real-world evidence,...
by Don McLean | Jun 13, 2019 | Blog
Developing Treatments for Rare Diseases – Reviewing Draft Guidance from the FDA by Amanda Beaster, PhD, Andrew Chervenak, PhD, Halina Chkourko Gusky, PhD, and Ingrid Hansen, MS New and updated regulatory guidances from the US Food and Drug Administration (FDA),...
by Don McLean | Jun 6, 2019 | Blog
11 Experts Discuss the Leadership Mindset of SOUL by Staff writer SOUL stands for bringing a Sense Of Urgency and Leadership to work each day. The SOUL of MMS comes to life as project work is completed on time and as risks and solutions are identified proactively. At...
by Don McLean | May 23, 2019 | Blog
Part 2: 505(b)(2) NDA – The Importance Early-Stage Planning by Ben Kaspar The unique aspects of the 505(b)(2) submission structure and label claims are perhaps best illustrated at the pre-IND planning stage. Whereas for a new chemical entity, pre-IND discussion is...
by Don McLean | Feb 14, 2019 | Blog
Regulatory Strategy, 505(b)(2) Applications, and Chess: A Conversation with Ben Kaspar by Staff writer In this Expert Insights interview, we sit down with Ben Kaspar, Global Submissions Manager at MMS, to discuss regulatory strategy, 505(b)(2) applications, and...
