Next Upcoming Seminar: Demystifying FSMA and the FSVP – July 25, 2017

Specializing in FDA Regulatory Matters

Product Applications

EAS Consulting Group assists clients with filing drug applications. Our Senior Director of Drug and Device Services works with our team of drug application experts to determine the best course of action, designs the studies necessary to support this, and files the application and/or any subsequent supplements on the clients’ behalf.

Application assistance includes:

505(b)(1) Application

A 505(b)(1) application is an application that contains full reports of investigations of safety and effectiveness. In such an application, the studies submitted for approval were conducted by, or for the applicant, or the applicant has obtained a right of reference or use for the investigations.

505(b)(2) Application

A 505(b)(2) application is an application that contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.

The applicant and FDA will rely on a previous findings of safety and effectiveness that led to approval of an NDA or on data not developed by the applicant such as published literature.

505(b)(2) applications are submitted under section 505(b) of the Act and are therefore subject to the same statutory provisions that govern 505(b)(1) applications in that they require, among other things, “full reports” of safety and effectiveness.

Abbreviated New Drug Application (505)(j)

An abbreviated new drug application is described under section 505(j) of the Act as an application that contains information to show that the proposed product is identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics and intended use, among other things, to a previously approved application (the reference listed drug (RLD)).

ANDAs do not contain clinical studies as required in NDAs but are required to contain information establishing bioequivalence to the RLD. In general, the bioequivalence determination allows the ANDA to rely on the agency’s finding of safety and efficacy for the RLD.

Supplement to an approved application

A supplement is a request to the FDA to approve a change in a human drug application which has been previously approved.  Each indication or claim is considered a separate change for which a separate supplement should be submitted.  This policy allows FDA to approve each indication or claim when it is ready for approval rather than delaying approval until the last of a group of indications or claims is ready to be approved.