As a continuation of FDA Communications: Part I, this article will discuss the other two major types of communications with the FDA that were not discussed in Part I. As a reminder, there are four major types of communications with the FDA:
- Administrative meetings and communications
- Regulatory communications
- Product application meetings
- Public administrative proceedings
This article will discuss the last two types of FDA communications, product application meetings and public administrative proceedings.
Product Application Meetings
The drug development process requires for the sponsor to have product application meetings with the FDA. There are three types of product application meetings for drugs and biologics:
- Type A- Dispute resolutions, clinical holds, Special Protocol Assessment (SPA) comments, and post-action meetings
- Type B- Review meetings for Pre-IND, End-of Phase 1, End-of-Phase 2, Pre-NDA, Pre-BLA, pre-use authorization meetings, post-action meetings, Risk Evaluations and Mitigation Strategies (REMS) discussions, and post-marketing requirements
- Type C- any other drug development or guidance meetings not included as Type A or Type B
All three types are formal and critical meetings with the FDA to discuss drug development and regulatory review points. The sponsor will find that Type B meetings with the FDA are useful at all drug development phases. Product application meetings are requested by the sponsor in writing and the FDA will either grant a live phone or in-person meeting or respond to sponsor in writing. The time window for the meetings to occur are different for each type of meeting. Type A meetings are 30 days from the request date and Type B meetings are 60 days from the request date. Type C meetings have the longest period at 75 days from the request date.
Public Administrative Proceedings
The purpose of having formal public administrative proceedings is to provide transparent communications between the public and FDA. The following are five types of Public Administrative Proceedings that are held:
- Advisory Committee Meeting- Third-party experts are able to provide recommendations to the FDA in reference to the safety and efficacy of product labeling, product approvals, research projects and other scientific issues
- Public Regulatory Hearing- A public meeting used by the FDA commissioner to obtain information prior to taking regulatory action
- Public Workshop- Workshops where the public, industry professionals, and the FDA can share and disseminate valuable information
- Board of Inquiry- Used as an alternative to a formal evidentiary hearing held at the discretion of the FDA commissioner with the purpose of reviewing medical or scientific issues
- Evidentiary Hearing- The purpose is to discuss critical public health issues and is ordered by Congress or the FDA commissioner
Public Administrative Proceedings can directly influence future FDA regulations and the drug development process. It is important for drug manufacturers to attend public workshops or public regulatory hearings that may give informative insight or changes in reference to drug development phases.
FDA meetings and communications may differ depending on the marketing application, however all interactions with the FDA are key to product development,particularly the drug development process. Clear and helpful communications with the FDA can lead to successful completion of the drug development phases. The utilization of regulatory experts with knowledge and experience with each meeting type is necessary in drug development, and essential in getting the drug to market faster.
Christina Sanchez Miller, MPH has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483’s, cGTP’s, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing.
Pharmaceutical Development Group (PDG) is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and FDA regulatory affairs. PDG is a pharmaceutical consulting group focusing on NDA regulatory services, FDA communications, and IND consulting services. PDG is a subsidiary of Biotech Research Group Corporation.
The opinions and statements in this blog are those of the authors and do not necessarily reflect those of PDG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.