Source: https://www.jdsupra.com/legalnews/505-j-or-505-b-helping-to-choose-the-36304/
Timestamp: 2019-05-24 03:54:24
Document Index: 250809302

Matched Legal Cases: ['§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 320', '§ 320']

505(j) or 505(b)? Helping to Choose the Proper Pathway | Locke Lord LLP - JDSupra
505(j) or 505(b)? Helping to Choose the Proper Pathway
Alan Clement, Myoka Kim Goodin
3. Intentional differences between the proposed drug product and the RLD:
a. Formulation differences
§ 314.93 Petition to request a change from a listed drug , 21 C.F.R. § 314.93
§ 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 , 21 C.F.R. § 314.54
§ 314.50 Content and format of an NDA , 21 C.F.R. § 314.50
§ 314.3 Definitions , 21 C.F.R. § 314.3
§ 320.21 Requirements for submission of bioavailability and bioequivalence data , 21 C.F.R. § 320.21