Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" for comments and on Monday (01 April 2024) released final guidance on "Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies".
In this guidance, instructions are provided for submitting expedited individual case safety reports (ICSRs) to FDA Adverse Event Reporting System (FAERS) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to support abbreviated new drug applications (ANDAs).
A ICSR contains information that is necessary to support the reporting of an adverse event associated with the use of an FDA-regulated product related to an individual subject. A safety report documenting a serious adverse event (SAE) experienced by a study subject during conduct of an IND-exempt BA/BE study must be submitted on Form FDA 3500A or in an electronic format that FDA can process, review, and archive.
FDA provides two options for electronic submission of ICSRs and ICSR attachments to FAERS:
ICSR Option A: Database-to-Database Transmission (“E2B”)
ICSR Option B: Safety Reporting Portal (SRP)
Electronic submission of ICSRs from BA/BE studies exempt from IND is a voluntary option for submitting these required reports.
This guidance aims to offer recommendations to applicants and testing site management on ensuring and preserving data integrity for the clinical and bioanalytical components of bioavailability (BA) and bioequivalence (BE) studies.
These studies are submitted in support of investigational new drug applications (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs), as well as the bioanalytical component of clinical pharmacologic studies supporting biologic license applications (BLAs) regulated by the Center for Drug Evaluation and Research (CDER). It also applies to amendments and supplements to these applications.
Additionally, FDA encourages applicants and testing sites to consider the recommendations in this guidance when conducting other studies, including in vitro, pharmacology, and toxicology. The recommendations in this guidance apply to the bioanalytical portion of nonclinical studies as well.
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