Our industry is on the cutting-edge of science aimed at developing new therapies for devastating and life-threatening diseases. To help advance innovation and promote the development of the next generation of treatments and cures, we must acknowledge that the scientific method does not operate in a vacuum. Robust, interactive FDA-Sponsor communication is a key element of modern drug development.
However, in order to improve the drug development enterprise and the FDA review process further, the biopharmaceutical industry must provide feedback on your experiences during drug development that will help inform public policies and BIO advocacy.
BIO is pleased to announce a first-of-its-kind, FDA Continuous Survey Initiative. We invite drug sponsors engaged in individual clinical programs for products currently in the pre-clinical-NDA/BLA submission stages of development to participate in the survey. Participants will receive exclusive benefits including webinars highlighting survey findings and direct access to data reports from the survey.
This is a new type of prospective survey initiative – participants will have the ability to access their online survey portal 24 hours a day, 7 days a week to input information or review your responses. BIO will analyze the data provided at minimum, twice a year.
Your participation will help serve these three goals:
- Enable BIO to inform FDA about its sponsor interactions during the pre-clinical to NDA submission in a more ‘real-time’ manner.
- Identify areas where policies, regulations, and practices are working well for sponsors and should not be changed, and areas that need improvement to make the process more efficient and effective.
- Inform the prescription drug user fee negotiations that will begin in late 2015 and continue through 2017.
Participants do not have to be members of BIO; all information will be protected and kept private. To participate in the survey smart scan the QR code below or visit bio.org/FDAsurvey