The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Draft Guidance on Oxymetazoline Hydrochloride.” The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support Read more

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.”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 Read more

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 Read more

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” This guidance finalizes the draft guidance of the same name published on October 30, 2019, and describes Read more

The Food and Drug Administration (FDA or the Agency) is announcing the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA Read more

The Food and Drug Administration (FDA or the Agency) is withdrawing approval of 30 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications Read more