Subject Line: Got a question for FDA? NCI SBIR can help.
Dear SBIR/STTR Awardee,
The NCI SBIR Development Center would like to invite you to participate in a free program CARE – Connecting Awardees with Regulatory Experts. The purpose of the CARE Program is to provide NCI SBIR/STTR-funded small businesses with an additional avenue for informal communication with FDA about their technologies.
If you are in the early stages of developing a technology that will be regulated by FDA (or you are unsure!) and have regulatory questions, consider taking advantage of this free opportunity to get feedback from the FDA.
Current NCI awardees that are developing a technology under the regulatory authority of any FDA Center (i.e., CBER, CDER, or CDRH) and have not met with FDA previously are eligible to participate.
Applications for the CARE pilot program will go through the following process:
NCI SBIR Development Center will collect applications and provide to the appropriate FDA Center (i.e., CBER, CDER, or CDRH).
CBER, CDER, or CDRH will review the regulatory questions and provide guidance on the appropriate group at FDA that can answer the questions.
Regulatory questions could be answered by FDA on an individual basis by a small business information office or an FDA Reviewer.
For regulatory questions that require more in-depth review, a pre‑submission meeting could be recommended.
This program is intended for early-stage companies that have not participated in CARE previously. Note, the CARE program does not replace any formal or informal meetings encouraged or required by FDA.
To participate:
Visit NCI SBIR’s regulatory resources webpage and check if your questions have already been answered here https://sbir.cancer.gov/resources/fda-resources.
Complete the attached application form and email it to [email protected].
Subject Line: NCI SBIR CARE program: please complete 2 min survey
Thank you for participating in the NCI CARE Program this year! I’d appreciate your feedback on what was/wasn’t helpful to your company.
We appreciate you taking a 4-question, multiple choice survey found at this link:
https://www.surveymonkey.com/r/LSBV5VF
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Zhang, Kehui (NIH/NCI) [C] |
| File Modified | 0000-00-00 |
| File Created | 2023-08-03 |