Update: July 5, 2018 Introduction On July 28, 2017, FDA alerted health care professionals of adverse event reports concerning at least 43 patients who were administered […]

1. FDA will continue to explore options for sharing information with states that have sunshine laws, including whether a modified information sharing agreement could be developed. […]

Under section 503A of the FD&C Act, bulk drug substances used in compounding must either be components of FDA-approved drug products, the subject of an applicable […]

Submit Comments by 09/26/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Summary Company Announcement Date: June 25, 2024 FDA Publish Date: June 26, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Failed dissolution Company Name: […]

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the […]

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the […]

FDA has reevaluated the rationale document titled, “Ceftaroline Breakpoints for Staphylococcus aureus,” submitted by the Clinical and Laboratory Standards Institute (CLSI) to FDA public docket # […]

For Immediate Release: June 26, 2024 Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from […]