The Biotechnology Innovation Organization (BIO) is surveying biotech companies about their interactions with the Food and Drug Administration (FDA), with the goal of improving communications between drug sponsors and the regulator.
BIO’s “FDA Communications Survey” is designed to obtain companies’ experiences, challenges, and lessons learned so we can provide recommendations for better communications between the FDA and biotech firms.
All biotech companies that have engaged with the FDA during the drug development process are invited to provide their feedback.
Biotechnology companies play a crucial role in advancing medical breakthroughs, bringing innovative treatments to patients, and shaping the future of healthcare. Central to their success is the ability to effectively communicate and collaborate with regulatory bodies like the FDA.
The FDA’s review and approval processes are designed to safeguard patient health and provide a framework for evaluating the safety and effectiveness of new treatments. Open lines of communication between biotech companies and the FDA are essential to facilitate a comprehensive understanding of each drug’s benefits and potential side effects. Efficient communication ensures that the regulatory process remains transparent, enabling biotech companies to align their efforts with FDA’s expectations and requirements.
“One of the most common remarks we hear from companies seeking FDA approval is that they need input and feedback from FDA that is both timely and reliable,” says Rachael Anatol, BIO’s Senior Vice President, Science and Regulatory Affairs. “Of course the FDA has limited resources and cannot always be available, but that’s exactly why it is important that the communication they do engage in with companies is effective and efficient.”
Details of the survey
The desire to improve communication with the FDA first inspired BIO to conduct an FDA Communications Survey ten years ago and it’s why they will conduct a similar effort again this year.
Previous surveys have been critical in our continuous efforts to work with FDA on best practices and to suggest changes during reauthorization of the Prescription Drug User Fee Act (PDUFA), which guides the relationship between the FDA and drug makers.
Respondents will be asked to spend about 10 minutes completing a short survey designed to obtain the following information:
- Company Profile: number of employees, products, programs, etc.
- Program Profile Phase, CDER/CBER/CDRH, Office, etc.
- Program Journal:
- Special Designations, if any.
- Communications Channels e.g., email, phone, letter, meeting, etc.
- Most recent interaction, specifically:
- Rating the most recent interaction (e.g., how beneficial was it?)
- What was most effective? What could have been more effective?
- Current phase interactions overall:
- Rating the interaction.
- What was most effective? What could have been more effective?
- Pre-Phase Discussions (to prepare for an upcoming phase):
- Rating the interaction.
- What was most effective? What could have been more effective?
- Clinical Hold, if any.
How to participate
BIO members who did not receive the survey launch email are encouraged to contact fdasurveysupport@bio.org to receive a link to participate. The survey is designed to capture longitudinal data over the course of drug development and does not have a closing date.
