FDA publishes new MAPP, Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings (5220.8)

FDA publishes new MAPP, Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings (5220.8)

Today, September 17, 2019, FDA published a new Manual of Policies and Procedures (MAPP 5220.8), “Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings.”

This MAPP outlines the policies and procedures of the Office of Generic Drugs (OGD) and the Office of Pharmaceutical Quality (OPQ) for 1) evaluating requests from prospective abbreviated new drug application (ANDA) applicants (prospective applicants) for product development and pre-submission pre-ANDA meetings and 2) conducting such meetings.

A prospective applicant may request a product development or pre-submission meeting through the CDER Next Gen Collaboration Portal. Once received, OGD and OPQ will evaluate the request and determine whether it should be granted or denied based on the criteria described in the GDUFA II Commitment Letter.

 FDA will grant a product development meeting if, in FDA’s judgment, the prospective applicant’s meeting package is complete and the requested meeting concerns either:

• The development of a complex product for which FDA has not issued a product-specific guidance OR
• An “alternative equivalence evaluation (i.e., change in study type, such as clinical to in vitro)” for a complex product for which FDA has issued a product-specific guidance.

FDA may also grant a product development meeting, dependent on available resources, if the requested meeting concerns product development issues other than those identified above (e.g., if FDA has developed a product-specific guidance and the prospective applicant is not proposing an alternative equivalence evaluation), and in FDA’s judgment, the prospective applicant’s meeting package is complete and a controlled correspondence response would not adequately address the prospective applicant’s questions, and a product development meeting would significantly improve ANDA review efficiency. Please refer to the MAPP for full details.

This MAPP was issued as part of FDA’s larger Drug Competition Action Plan, which lays out the agency’s plans to streamline the ANDA assessment process, provide clarification and assistance to current and prospective applicants, and, ultimately, expand access to lower cost, high quality medicines. ANDAs for complex generic drug products may involve more review cycles than standard products. The agency has therefore worked to develop guidances, policies, and processes that clarify when additional assistance may be available for complex product applications. These efforts may facilitate the submission of ANDAs and the introduction of more generic medicines to the complex drug marketplace, which has generally faced limited competition.

Resources:

• Direct link to MAPP
• FDA Pre-ANDA Program
• CDER Next Gen Collaboration Portal
• Draft guidance for indust