COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, May 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products COVID-19 -- drug therapy Drug Approval Drug Industry Drugs, Investigational Drug Evaluation, Preclinical Investigational New Drug Application United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide general considerations to assist sponsors in preparing pre-investigational new drug application (pre- IND) meeting requests for COVID-19 related drugs1 for the duration of the COVID-19 public health emergency. As described in further detail in this guidance, FDA recommends that sponsors initiate all drug development interactions for COVID-19 related drugs through IND meeting requests. This guidance is intended to provide sponsors with an initial framework to help organize their preIND meeting requests during the COVID-19 public health emergency. This document is intended to complement other guidance documents providing recommendations regarding drug development programs for COVID-19, including the guidance for industry COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (May 2020).
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (10 pages)).
- NLM Unique ID:
- 9918231202606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918231202606676