Annual Updates on Labeling Changes for NDAs and ANDAs Regarding Nonprescription Medications
On March 2024, the FDA is releasing a draft guidance for industry that, once finalized, will offer suggestions to holders of approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) for nonprescription drug products on how to document minor labeling changes in their subsequent annual reports.
US FDA Publish Additional Condition for Nonprescription Use (ACNU)
On June 2022, the FDA introduced a new regulation aimed at establishing criteria for over-the-counter drugs that carry an Additional Condition for Nonprescription Use (ACNU). This initiative seeks to expand the range of drugs that the FDA could authorize for over-the-counter use.
The US FDA Updates Meeting Procedure for under PDUFA VII and BsUFA III
Starting February 2023, The US FDA Updates Meeting Procedure for under PDUFA VII and BsUFA III
FDA fills in the details with guidance for Marketing Status Notification
In 2017, the Reauthorization Act (FDARA) made it mandatory for drug marketing holders to notify the FDA about the status of the NDA or ANDA product withdrawal. The FDA releases guidance on how to update the FDA appropriately.