Protecting participants in bioequivalence studies for abbreviated new drug applications during the COVID-19 public health emergency

Protecting participants in bioequivalence studies for abbreviated new drug applications during the COVID-19 public health emergency

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.). Office of Generic Drugs. issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021
Language(s):
English
Format:
Text
Subject(s):
Drug Approval
Patient Safety
Therapeutic Equivalency
COVID-19
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 recommendations to prospective applicants of abbreviated new drug applications (ANDAs) on ensuring the protection of participants when resuming or initiating bioequivalence (BE) studies conducted to support the approval of an ANDA that have been disrupted during the COVID-19 public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
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:
9918250311606676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918250311606676