Department of Health and Human Services February 22, 2024 – Federal Register Recent Federal Regulation Documents
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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; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``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.'' Although the public health emergency declared by the Department of Health and Human Services under section 319 of the Public Health Services Act has ended, COVID-19 remains an ongoing public health problem with continued prevention and treatment efforts. FDA is issuing this guidance to provide sponsors and investigators with considerations for approaches on how common COVID- 19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adult and adolescent subjects. This guidance supersedes the guidance of the same name issued on September 29, 2020.
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance.'' The guidance includes select updates to the guidance ``Medical Device User Fee Small Business Qualification and Certification'' which describe how FDA plans to determine if a small business is experiencing ``financial hardship'' which makes them eligible for a waiver of their registration fee. The guidance will detail what information FDA will review and consider in making this determination. This draft guidance is not final nor is it for implementation at this time.
Advisory Committee; Digital Health Advisory Committee; Addition to List of Standing Committees
The Food and Drug Administration (FDA or Agency) is amending the standing advisory committees regulations to add the establishment of the Digital Health Advisory Committee (the Committee) to the list of standing advisory committees.
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