OGD Explains How it Reviews and Conducts Pre-ANDA Meetings
In a newly issued manual of policies and procedures (MAPP), the US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) explains how it evaluates and conducts two types of meetings under its pre-abbreviated new drug application (ANDA) program.In the eight-page MAPP, the office explains its criteria for granting or denying product development and pre-submission pre-ANDA meetings. The MAPP also provides timeframes for how the agency conducts those meetings.
FDA committed to provide both types of meetings under the second iteration of the Generic Drug User Fee Amendments (GDUFA II) to clarify regulatory expectations for applicants and assist applicants with putting together "more complete" ANDAs.
"The meetings relevant to this MAPP include both product development meetings and pre-submission meetings, which are intended to allow prospective applicants to discuss their development of these products before they submit and ANDA. In particular, for prospective applicants developing complex generic drug products," FDA writes.
To request a meeting, FDA says applicants may send an email to OGD or submit a request via the Center for Drug Evaluation and Research (CDER) Next Gen Collaboration Portal.
For product development meetings, FDA says it will grant meetings to applicants who submit complete meeting packages for complex products that are not covered under existing product-specific guidance or for complex products where the applicant is seeking an alternative approach to what FDA has described in product-specific guidance.
FDA also says it may grant product development meetings, resources permitting, to address other development concerns for complex products; to address issues that could not be adequately addressed via correspondence; or in cases where a product development meeting "would significantly improve ANDA review efficiency.”
For pre-submission meetings, FDA says it will generally grant meeting requests for sponsors who already have had a product development meeting. The agency also says it may consider granting pre-submission meetings to applicants developing complex generics if the meeting would improve the efficiency of reviewing an ANDA.
FDA says it will notify applicants as to whether their requests have been granted or denied via the Next Gen Collaboration Portal. When meetings are denied, the agency says it will include an explanation for the denial and "will generally provide a path forward for future communication" either through controlled correspondence or a revised meeting package.
The MAPP also breaks up the timeframe for reviewing meeting requests, carrying out meetings and post-meeting communication into three stages.
Within 14 days of receiving a meeting request, FDA says it will conduct preliminary request screenings, meeting request assessments and decide whether to grant or deny a meeting.
Within 120 days of a meeting being granted, FDA says its meeting package assessment team will review the meeting package. For face-to-face and teleconference meetings, FDA will then send a letter informing applicants of the date and time of the meeting and make preparations for the meeting such as drafting and sharing preliminary comments. When a written response is requested, FDA says it will prepare and send a written response to the applicant, "which will serve as the final response from FDA" and close out the meeting.
After hosting a face-to-face or teleconference meeting, FDA says it will share a post-meeting summary with the applicant within seven days. Within 30 days of the meeting, the meeting project manager will draft and share the meeting minutes with the applicant.
FDA