# Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment :  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/assessing-covid-19-related-symptoms-in-outpatient-adult-and-adolescent-subjects-in-clinical-trials-of-drugs-and-biological-products-for-covid-19-prevention-or-treatment-guidance-for-industry/3993ff56-2b20-4679-8303-9876c6800402

> FDA guidance document: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment :  Guidance for Industry. Issue date: February 22, 2024. Get complete insights and analysis.

---

## Details

- Title: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment :  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2024-02-22
- Last Changed: 2024-02-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-1824">FDA-2020-D-1824</a>

## Related Documents

- [Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies](https://www.globalkeysolutions.net/guidances/guidance-document/enhanced-drug-distribution-security-requirements-under-section-582g1-of-the-federal-food-drug-and-cosmetic-act-compliance-policies/81e414c7-4ee9-4a96-aba3-257bbafce4bd)
- [COVID-19: Developing Drugs and Biological Products for Treatment or Prevention:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/covid-19-developing-drugs-and-biological-products-for-treatment-or-prevention-guidance-for-industry/a6c3249b-9395-4d0b-96dd-986a992b4139)
- [Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/wholesale-distributor-verification-requirement-for-saleable-returned-drug-productcompliance-policy-guidance-for-industry-guidance-for-industry/9c37f21d-8925-4eca-96b6-c5ce923c6966)
