2024 21 CFR 314.54 – Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
2023 21 CFR 314.54 – Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
2022 21 CFR 314.54 – Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
2021 21 CFR 314.54 – Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
2020 21 CFR 314.54 – Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
2019 21 CFR 314.54 – Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
2016 21 CFR 314.54 – Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
2015 21 CFR 314.54 – Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug
2014 21 CFR 314.54 – Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug
2010 21 CFR 314.54 – Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug
2009 21 CFR 314.54 – Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug.