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...
by Don McLean | Feb 7, 2019 | Blog
Safety Writing, REMS, and Regulatory Requirements: A Conversation with Jeffrey Wiese by Staff writer In this Expert Insights interview, we sit down with Jeffrey Wiese, Senior Safety Writer at MMS – to discuss safety writing in the pharmaceutical industry,...
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 Don McLean | Jan 17, 2019 | Blog
Writing for Regulatory Agencies vs. Medical Journals: The Differences by Megan Day, AA, BA, PhD (ABD) When a clinical trial is completed, regardless of the outcome, the results need to be shared. From a regulatory perspective, they have to be shared. On the other...
