Guidance Explains Expectations for Sponsor-FDA Meetings
The FDA outlined new deadlines and procedures for the way drugmakers seek and conduct meetings with the agency before and during reviews of new product submissions.
The six major changes unveiled by the FDA include giving companies the opportunity to request written responses to questions before filing an IND for a drug or biologic. The FDA says it will notify firms of its intended response date within 21 days of receiving such a request. The other five changes discuss new meeting types and the information packet that accompany requests.
The revisions, laid out in draft guidance that replaces a 2009 document, are intended to align sponsor-FDA meetings with the goals laid out for pre-NDA and -BLA meetings in PDUFA V.
The changes occur within the existing FDA framework for Type A, B and C pre- and postsubmission meetings:
Type A meetings are used to help restart a stalled development program. The revised draft creates meetings to address important safety issues in the Type A category, along with meetings to discuss clinical holds. Under the new deadlines, if a company requests a meeting date more than 30 days after the FDA receives a Type A meeting request, the meeting should occur within 14 calendar days of the sought date, the guidance says.
Also new in the guidance, companies requesting a Type A meeting should create a meeting package in their request with the proposed agenda, a summary of results of relevant clinical studies, any decisions the company took based on those results and the product’s chemical name and structure.
Type B meetings are routine meetings tied to the submission of clinical data and an NDA.
The same 14-day limit established for Type A meetings also applies to Type B meetings, but when the requested meeting date is more than 60 days after the FDA receives the request.
Preemergency use authorization meetings are now categorized as Type B meetings, as are meetings on risk evaluation and mitigation strategies and postmarketing requirements outside the context of NDA review, and meetings to discuss development programs for breakthrough drugs.
Type C meetings cover everything not covered in Type A or B. For Type C meetings, the new deadlines call for the FDA’s written response to come within 75 days of receiving the request. Meetings requested more than 75 days after the agency gets the request should be scheduled within 14 calendar days.
For Type B or C meetings, meeting requests should note the date the firm intends to send the meeting package, ideally within one month of the meeting date.
Comments on the draft guidance, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products, are due June 9. View it at www.fdanews.com/03-10-15-PDUFAmeetings.pdf. — Lena Freund