by Prakash Achaary | Nov 30, 2022 | Blog
With all new regulations like Health Canada-PRCI, EMA Policy 0070 and EU-CTR requiring the publication of clinical information, it’s important to understand what is considered company confidential information (CCI) and how to protect the information being shared with...
by Prakash Achaary | Nov 30, 2022 | Blog
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...
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 30, 2022 | Blog
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...
by Prakash Achaary | Nov 29, 2022 | Blog
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...