The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” The draft guidance, when finalized, will provide recommendations to the dietary supplement industry on Master Files for new dietary ingredients. The purpose of this draft guidance, when finalized, will be to help industry comply more easily with the new dietary ingredient notification requirement by providing recommendations on the submission and use of Master Files that contain identity, manufacturing, or safety data that can be used to support a new dietary ingredient notification. New dietary ingredient Master Files are submitted solely at the discretion of the Master File owner and are not required by statute or regulation.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Draft Guidance on Oxymetazoline Hydrochloride.” The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for oxymetazoline hydrochloride ophthalmic solution.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” The purpose of this guidance is to provide recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted in support of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and the bioanalytical portion of clinical pharmacologic studies supporting Center for Drug Evaluation and Research-regulated biologic license applications (BLAs) as well as amendments and supplements to these applications. In addition, the recommendations in this guidance apply to the bioanalytical portion of nonclinical studies. FDA also encourages applicants and testing sites to consider these recommendations when conducting other studies, including in vitro and pharmacology and toxicology studies.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.” This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies to the FDA Adverse Event Reporting System (FAERS). This guidance finalizes the draft guidance entitled “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies” issued on August 3, 2022.