REVIEW ON SPONSOR / APPLICANT MEETINGS WITH FDA: HIGHLIGHTS OF NEW GUIDANCE OVER EXISTING
The United States Department of Health and Human Services has a federal agency called the Food and Drug Administration (FDA or USFDA). A pre-planned assembling of two or more people who have been together for the purpose of getting a common goal via verbal interaction is called a formal meeting. During development stage of any drug or biological products pharmaceutical companies face trouble for both scientific and regulatory point of view, here role of formal meetings comes. Formal meetings between sponsor or applicant and FDA are usually related to development and review of drug and biological products. Center for Drug evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regulates the formal meetings. These meetings are applicable to Pre – Investigational New Drug Application, Pre – Biologics License Application, New Drug Application for drugs and biological products and not applicable to Abbreviated New Drug Applications (ANDA), application of medical devices and submission of biosimilar biological products. Meetings between FDA and sponsor or applicant are for resolution of dispute, clinical holds discussion, Assessment of protocols of clinical trial, during clinical trials, in between clinical trials – at the phase 1 ending or at the phase 2 ending, to discuss development program. The FDA has classified these formal meetings in different types based on the nature of the request, the information in the meeting request and each meeting type is handled through different procedures. The principles of Good Meeting Management Practices (GMMPs) must be maintained. There are specific requirements and procedures to request, prepare, schedule, conduct and document formal meetings. As the guidance documents for meetings are revised by FDA, Change in procedure and requirements takes place. Any pharmaceutical company need to be in line with new guidance requirements to avoid rejection. Formal meetings between sponsor or applicant and FDA save time, cost and will increase the probability of product approval.
2. Events U, Review R, Drug D, Public D. Communicating with CDER. 2013; (1):1–2.
3. Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry [Internet]. Federal Register; 2015 [cited 2016 Apr 21]. Available from:
4. Food and Drug Administration. Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants; 2009 (Revision 1).
5. Issue IT, Communications AB. Best Communications Practices with FDA. 2016; 1–3.
6. Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants; Guidance for Industry [Internet]. Federal Register; 2015 [cited 2016 Apr 21]. Available from:
7. Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants [Internet]. Federal Register [cited 2016 Apr 21]. Available from:
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM