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 31, 2019 | Uncategorized
Tips for Nonclinical Pharmacology and the Medical Writers that Draft Regulatory Submissions by September Mihaly, Ph.D., RAC Summarizing nonclinical studies in Module 2.6 of the common technical document (CTD) takes a unique skillset. These studies include...
by curtis@digitalliance.com | Jun 14, 2018 | Blog
Society needs to change to embrace open discussions on suicide by Uma Sharma One person dies from suicide every 40 seconds across the globe according to the World Health Organization (WHO), and the world is currently mourning two, with the unfortunate circumstances...
