Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry

Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry

Collection:
Health Policy and Services Research
Contributor(s):
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Language(s):
English
Format:
Text
Subject(s):
Antibodies, Monoclonal
COVID-19 Drug Treatment
Drug Approval
Drug Industry
Government Regulation
Legislation, Drug
SARS-CoV-2
United States
Genre(s):
Guideline
Technical Report
Abstract:
FDA is issuing this guidance to provide recommendations to sponsors on the development of monoclonal antibody (mAb) products targeting SARS-CoV-2 intended for the prevention or treatment of COVID-19, including recommendations on addressing the impact of emerging variants. In February 2021, FDA published the guidance for industry Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency (February 2021). The guidance was published as part of the Agency’s efforts to facilitate the development and availability of COVID-19 therapeutics for the duration of the COVID-19 public health emergency (PHE), as declared under section 319 of the Public Health Service Act (PHS Act). In the Federal Register of March 13, 2023 (88 FR 15417), FDA listed certain COVID-19-related guidance documents that FDA was revising to continue in effect for 180 days after the expiration of the COVID-19 PHE declaration on May 11, 2023, during which time FDA planned to further revise the guidances. The February 2021 guidance on development of monoclonal antibody products targeting SARS-CoV-2 was included in this list.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (11 pages))
NLM Unique ID:
9918751183806676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918751183806676