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Building a collaborative relationship with the U.S. Food and Drug Administration (FDA) is an essential component of a robust product development strategy for sponsors intending to bring novel drugs, biologics, and/or devices to market. Fortunately, the FDA offers various opportunities for interaction and guidance throughout the development lifecycle. FDA meetings provide an opportunity for sponsors to educate the agency about their product(s) and the corresponding development strategies.

In turn, these meetings allow sponsors to seek input regarding available data, discuss evolving regulatory requirements, and identify potential gaps in the overall product plan. These interactions are often an invaluable tool for de-risking product development, particularly for sponsors advancing highly complex product modalities and/or pursuing novel therapeutic targets.

FDA MEETINGS

Type A Meetings that are “necessary for an otherwise stalled product development program to proceed (a critical path meeting) or to address an important safety issue.”

Type B Pre-IND The purpose is to obtain FDA feedback on the drug development program and de-risk any potential clinical hold issues during the FDA review of the IND.

Type B End of Phase

The purpose is to discuss and de-risk the study design for the next clinical trial and to ensure the CMC and nonclinical aspects of the program are in line with the FDA’s expectations for the next phase of development.

Type C Considered the “catch-all” category and includes any meeting concerning the development and review of a product that does not fall within the scope of other meeting types.

Type D New for PDUFA VII – Intended for follow-up on a limited number of topics and are useful for gaining additional clarification or negotiating a particular issue in a development program.

INTERACT New for CDER for PDUFA VII – Now for both biologics and drugs. Useful for early-stage settings. Typically used for setting nonclinical and early CMC strategies and do not take the place of a PreIND meeting.

Pre-Sub CDRH meeting that occurs most frequently. Opportunity to obtain FDA feedback before premarket submission and ask product development questions.

We are passionate about life sciences and dedicated to being your trusted partner. By collaborating with us, you'll benefit from our extensive industry expertise and innovative strategies, guiding your company through the intricate clinical, regulatory, and quality landscape. With our proven track record in overcoming complex ecosystem challenges and expediting development timelines, you can concentrate on groundbreaking science while we take care of the rest. Together, we will maximize your company's potential, driving both clinical and commercial success.

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