Drugs

Development, Pre-Submission Meeting MAPP

CDER has issued a Manual of Policies and Procedures (MAPP) outlining the policies and procedures of the Office of Generic Drugs and Office of Pharmaceutical Quality for (1) evaluating requests from prospective ANDA applicants for a product development or pre-submission pre-ANDA meeting; and (2) conducting such meetings. Under GDUFA 2, the MAPP says, FDA committed to establishing a program to, among other things, clarify regulatory expectations for prospective applicants and assist the applicants to develop more complete ANDA submissions.

As part of that commitment, it agreed to conduct a series of meetings with prospective applicants within specific time frames. CDER says meetings relevant to the MAPP include both product development meetings and pre-submission meetings that are intended to allow prospective applicants to discuss their development of products before they submit an ANDA.

The MAPP includes the agency’s criteria for granting meetings and discusses how its decisions will be communicated.

Gupta Raises Concerns About Overton’s Independence, Ideology

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome