by Prakash Achaary | Nov 23, 2022 | Blog
Quality control (QC) is an essential step in developing regulatory documents. However, not all QCs can be done in a standard way or on usual documents. In this blog, we’ll discuss how to set yourself up for success when you need bespoke QC. What is Quality Control...
by Prakash Achaary | Nov 21, 2022 | News
CANTON, Mich. (11/21/2022) – MMS Holdings, a data-focused contract research organization (CRO), has been named a 2022 award winner of the Michigan Top Workplaces by the Detroit Free Press Top Workplaces. This is the second year that MMS has been recognized with this...
by Prakash Achaary | Nov 15, 2022 | Blog
In the PDUFA VII Commitment Letter, FDA announced its intention to roll out the Rare Disease Endpoint Advancement (RDEA) Pilot Program next year. This program is intended to address some of the unique challenges rare disease researchers face when determining endpoints...
by Prakash Achaary | Nov 15, 2022 | Blog
In the PDUFA VII Commitment letter, the FDA announced the establishment of the Split Real-Time Application Review (STAR) Pilot Program. The goal of the STAR pilot program will be to decrease the time from the date of the complete submission to the PDUFA action date...
by Prakash Achaary | Oct 26, 2022 | Blog
The Prescription Drug User Fee Act (PDUFA) VII, the 6th reauthorization of PDUFA, was signed by President Biden on September 30, 2022. In addition to the standard content that ensures the FDA has the necessary resources to provide a predictable and efficient review...