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 | May 16, 2019 | Blog
Part 1: 505(b)(2) NDA – Navigating the Regulatory Pathway by Ben Kaspar The 505(b)(2) is a New Drug Application (NDA) containing full reports of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by...
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...
by Don McLean | Jan 10, 2019 | Blog
How Real World Data is Changing the Pharmaceutical Industry by Erin Booth, PhD Approximately 90 percent of global pharmaceutical companies are using, or have plans to use real world data in the near future, according to a 2018 benchmarking survey from Deloitte. This...
by Don McLean | Oct 25, 2018 | Blog
Four initiatives to combat the opioid epidemic by Jeffrey Wiese and Julie Legakis This article was drafted based on a presentation given at the 9th Annual Scientific Symposium presented at MMS global headquarters in Canton, Mich. Opioid use in the U.S. is widespread....
