The PDUFA VII Commitment Letter builds on the programs supporting the use of Real-World Evidence (RWE) in regulatory decision-making begun under PDUFA VI. Specifically, the following initiatives incorporating RWE have been incorporated into PDUFA VII: Pilot Advancing...
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...
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...
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...
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...
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...
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...
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...
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...