As per the Requirements, for a generic drug without an RLD, the applicant should submit a type-III meeting application to communicate with CDE, in accordance with the Provisions for Communication About Drug R&D and Technical Review. Additionally, for the generics exempted from clinical trials, the applicants should also have the meeting with CDE to undergo product-by-product analysis.

Related:

• Notice on Studies on Generic Drugs Without Reference Listed Drugs (RLDs)

• Technical Requirements and Application Dossier Requirements for Studies on Generic Drugs Without Reference Listed Drugs (RLDs)