by Prakash Achaary | Mar 4, 2020 | News
MMS Holdings to Debut Datacise Integrated Safety Explorer to Detect Safety Signals Using Real-World Evidence During PHUSE/FDA Data Science Innovation Challenge CANTON, Mich. (March 4, 2020) – MMS Holdings (MMS) – an award-winning, data-focused CRO – announced today...
by Prakash Achaary | Aug 15, 2019 | Blog
Summer reading isn’t reserved for school-aged children, as adults and professionals alike can gain knowledge and insights from consistently reading material during the hottest months of the year. With Book Lover’s Day last week, we asked eight colleagues from varying...
by Prakash Achaary | Jun 13, 2019 | Blog
New and updated regulatory guidances from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and other global health authorities are continually being release. These guidances are...
by Prakash Achaary | 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 Prakash Achaary | 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...