by Avery Zimmerman | May 23, 2019 | Blog
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 generally focused on the determination of a safe starting dose in humans, the...
by Avery Zimmerman | May 16, 2019 | Blog
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 or for the applicant and for which the applicant has not obtained a...
by Avery Zimmerman | Feb 14, 2019 | Blog
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 general submission advice for any global companies outside of the US that plan to submit to the FDA. In...
by Avery Zimmerman | 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
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 surrounding Kate Spade and Anthony Bourdain. However, suicidality is not always...
