MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Updates to FDA Meetings under PDUFA VII
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...
Drug Safety Updates: What’s New Under PDUFA VII?
Patient safety remains at the forefront of the FDA's intentions to continue and enhance existing drug safety programs and develop new ones under PDUFA VII. Commitment to Enhanced Communication on Risk Management Activities During Review Some of the planned...
CMC and Quality Enhancements Under PDUFA VII Explained
FDA establishes numerous enhancements to product quality and chemistry, manufacturing, and controls (CMC) approaches in PDUFA VII to facilitate timely access to safe, effective, and innovative new medicines for patients, including: product quality reviews; CMC...
Ensuring Success When Planning and Implementing High-Impact Bespoke QCs
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...
MMS Named Michigan Top Workplace For The Second Consecutive Year
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...
What is the Rare Disease Endpoint Advancement Pilot Program and What Does it Mean for Rare Disease Research
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...
Split Real-Time Application Review (STAR) Pilot Program Explained: PDUFA VII Updates
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...
Prescription Drug User Fee Act (PDUFA) VII Updates Explained
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...
eCOA and ePRO: Embrace Accurate and Efficient Real-Time Electronic Data Collection
Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient Reported Outcomes (ePRO) are innovating the clinical trial industry. It’s time for Sponsors to embrace accurate and efficient real-time electronic data collection directly from patients, in the...
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