For more information on FDA's Project Catalyst, please visit:
https://www.fda.gov/OCECatalyst
Criteria for participation by Academic Life Science Hub or Small Company:
  1. The development program for this product (drug, biologic) has not had any formal interactions with FDA i.e. Interact Meeting or Pre-IND.
  2. The sponsor is an academic group (either through a Life Science Hub or Academic Accelerator) or a small company (less than 20 employees).
  3. These meetings provide non-binding guidance on oncology drug development.
  4. The goal is to provide product-type advice, education, and direction to enable a future successful Interact or pre-IND meeting.
  5. They are informal, introductory, encouraging encounters with regulatory experts.
  6. Prior registration is needed to obtain a date and time for your meeting.
There are a limited number of meeting slots available. If you are interested in participating, please complete this preliminary registration form. If we can accommodate your request, we will contact you with more details regarding the meeting format, required briefing materials, and scheduling.

Kindly preregister and allow time for follow-up and confirmation.

Question Title

* 1. Name:

Question Title

* 3. Affiliation / Organization:

Question Title

* 4. Product Description:
Describe in 1-2 paragraphs the type of oncology drug product that you intend to develop and the disease indication(s).

You control the information you provide when you enter a response in an open field text box presented in this registration. Please take care not to include sensitive personally identifiable information (PII) or information of a personal nature about yourself or others. Aside from your name and email address for intended registration purposes, do not include names, contact information, full or partial Social Security number, dates of birth, employee number, medical information or any other sensitive or personal data.

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