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# CDER Recommendations on IND Inquiries for Covid Drugs
- URL: https://www.fdaweb.com/cder-recommendations-on-ind-inquiries-for-covid-drugs/
- Published: 2020-05-12T12:00:00.000Z
- Updated: 2026-09-14T16:14:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146766

CDER has outlined recommendations for drug sponsors seeking product development inquiries for Covid-19 products. For example, the Center’s Office of New Drugs (OND) recommends that development for Covid-19 related drugs be supported by randomized controlled trials. OND also urges sponsors to seek initial advice under a pre-IND meeting request for investigational uses. “Submission of materials through a pre-IND meeting request helps ensure that discussions between OND and the sponsor proceed efficiently so that we can get promising therapies into studies quickly,” the office says. “To facilitate review, the pre-IND meeting request should include all relevant materials for the agency’s evaluation, including the meeting package, questions, and protocol.”

OND also has established a Covid-19 scientific/technical triage team to ensure the completeness and sufficiency of the information provided by sponsors for expedited reviews. The team will communicate with sponsors about additional information needed for divisional assignment and review. Once information is determined to be sufficiently complete, the team will communicate a division assignment to the sponsor and forward the submission to the OND review division for expedited review, FDA says.

General advice about pre-IND meeting request content is provided at [Covid-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-public-health-emergency-general-considerations-pre-ind-meeting-requests-covid-19-related?ref=fdaweb.com), and advice about clinical development of Covid-19 drugs is provided at [COVID-19: Developing Drugs and Biological Products for Treatment or Prevention](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-developing-drugs-and-biological-products-treatment-or-prevention?ref=fdaweb.com).

Additionally, the agency recommends sponsors email general questions to *Covid19-productdevelopment@fda.hhs.gov* mailbox. Sponsors of CBER-regulated drugs with questions about pre-IND meeting requests or office assignments should email CBER at *CBERProductJurisdiction@fda.hhs.gov*.