by Prakash Achaary | Nov 30, 2022 | Blog
Sponsors receive FDA feedback and advice on their drug development program via formal FDA meetings. These meetings allow Sponsors to learn the FDA’s current thinking on a specific topic and to amend their development program based on FDA’s recommendations...
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 | 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...
by Prakash Achaary | Aug 27, 2020 | Blog
[Fill out the form below to access the whitepaper] The Orphan Drug Act, established in 1983, provides incentives to sponsors for promoting the development of drugs for the prevention, diagnoses, and treatment of rare diseases or conditions that affect fewer than...
by Prakash Achaary | May 5, 2020 | News
CANTON, Mich. and SHANGHAI (May 5, 2020) – MMS Holdings Inc. (MMS) – an award-winning, data-focused CRO – announced that a successful collaboration with Shanghai-based Green Valley Pharmaceutical Co. (Green Valley) resulted in gaining U.S. Food & Drug...
