Given the numerous inquiries from prospective sponsors interested in conducting clinical trials for COVID-19 products, FDA has issued new guidance to assist sponsors in preparing Type B pre-investigational new drug application (pre-IND) meeting requests for COVID-19 related drugs and biologics1. This new guidance document was implemented without prior public comment and is intended to remain in effect only for the duration of the public health emergency, acting as a substitute for the current draft guidance on formal meetings2. Noteworthy points from the new guidance include:
- “Urging” sponsors of potential therapeutics for COVID-19 to seek initial advice from FDA under a pre-IND meeting request, instead of a pre-emergency use authorization (pre-EUA) request.
- For sponsors who already have an active IND or an FDA-approved drug for a non-COVID-19 indication, FDA recommends submitting a new pre-IND meeting request for the proposed COVID-19 indication, rather than amending their existing application.
- The pre-IND meeting request and briefing package development process will be consolidated into a single step. This is a deviation from the standard timeline for Type B meetings, in which case the briefing package would normally be due 30 calendar days prior to the meeting date.
- Content recommendations for the pre-IND meeting request are discussed in-depth (e.g., the submission should include a draft clinical protocol and a trial time/event table) along with special quality considerations for severe COVID-19 illness (e.g., administration of oral dosage forms to intubated patients).
- Acknowledgement from FDA that pre-IND meeting requests will be “generally responded to as a written response only (WRO) meeting” as opposed to a face-to-face or teleconference meeting.
- Although there are three options for submitting a pre-IND meeting request, the preferred method is through the Electronic Submissions Gateway (ESG).
1 Food and Drug Administration (FDA). (May 2020). Guidance for Industry and Investigators: COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products. Retrieved from source.
2 Food and Drug Administration (FDA). (December 2017). Draft Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products. Retrieved from source.