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.