Overview
In an effort to support sponsors responding to the public health emergency of the COVID-19 pandemic, the FDA provided a guidance to assist sponsors in preparing pre-IND meeting requests for COVID-19 related drugs (human drugs and biological products).
Pre-IND Process During Public Health Emergency for COVID-19:
The typical pre-IND meeting request and package development process has been consolidated into a single step by the FDA. Sponsors are to submit the pre-IND meeting request with any specific questions through the new pre-IND meeting request process. The meeting requests will be expedited and prioritized based on completeness of the submission and scientific merit and are generally responded to as a written response only meeting. If a sponsor has already has an active IND for drug in development, or has submitted a pre-IND meeting request or IND to the FDA to investigate the use of the FDA approved drug for a non-COVID-19 indication, it is recommended that a new pre-IND meeting request for a proposed COVID-19 indication is submitted, rather than amending current submissions.
Pre-IND Meeting Request for COVID-19 Drug Development
FDA recommends incorporating the following content that supports the clinical development program:
- Drug description (name, characteristics, proposed indication, dosage information, mechanism of action),
- Manufacturing and formulation for clinical study,
- Summary of pharmacokinetic information
- Summary of nonclinical pharmacology and toxicology data (FDA-approved label may suffice in some cases) including results of in vitro and in vivo studies
- A battery of nonclinical studies to support a first-in-human trial, including assessment of standard and applicable safety pharmacology studies should be included for small molecule drugs and biological products
- Summary of data and literature to support proposed use in COVID-19
- Clinical information to support proposed trial, including justification for proposed dosing information, summary of drug’s safety data in previous clinical trials, detailed safety monitoring plan, and a time and event table
- Sufficient product information to ensure acceptable quality, such as identity, purity, strength/potency, and stability of the investigational drug
Submission of Pre-IND Request:
Sponsors will have three options for submitting their pre-IND meeting requests:
- Option 1 (preferred): Electronic Submission Gateway (ESG)
- Option 2: for CDER pre-IND meeting requests – NextGen Portal
- Option 3: for CBER pre-IND meeting requests that cannot be sent through ESG – email CBERDCC_eMailSub@fda.hhs.gov
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.. To learn more, please contact us at info@globalregulatorypartners.com