The Significance of Early FDA Interactions

Pharmaceutical, medical device, and biotech companies have similar road blocks when navigating through FDA’s tough terrain. Regardless of whether a company is looking for guidance with FDA establishment registration, 510 k premarket notification or US FDA ANDA, each can be tricky unless tackled correctly. It is important to note that if a company decides to file FDA submissions internally or hire a regulatory services consulting firm to make the submissions, early interactions with the FDA are critical to the success of project timelines. An example of early interactions is a Pre IND meeting FDA. When guidance cannot provide the information needed, the Pre IND meeting FDA allows a pharmaceutical company to have their questions addressed as it will assist them with their planning in a drug development program.

If a company is developing a product intended to treat a serious or life-threatening disease, new to drug development, or there is a novel indication, it will be beneficial to request a pre-IND meeting. Early FDA communications can prevent clinical hold issues from occurring. A pre-IND meeting is valuable in providing information regarding preparation of an investigational new drug application.

The pre-IND meeting can be viewed as a Q&A session with the objective of having all your concerns addressed so the development process is done without delay. The most single advantage for requesting a pre-IND meeting is to develop a strategic plan with the help of the FDA, such as the sponsor can avoid unnecessary studies and focus their attention on providing useful information with the required studies. These early interactions with the FDA can lead to efficient drug development programs which will result in an advancement to the next stage of drug development- IND (investigational new drug application) and clinical trials. A knowledgeable pharmaceutical consulting firm can advise on different pathways such as fast track, accelerated approval, orphan drug or can select the right 505(b) application to file. A pharmaceutical consultant will ensure your meeting request has the necessary documentation, such as a meeting objective, proposed agenda, questions strategically categorized and ingredient quantitative composition.

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The FDA will want to know who will be attending the meeting from your organization and which CDER personnel you will be requesting to participate. There is a large quantity of information that the FDA will request at the meeting. For that reason, the person taking lead of the meeting should be knowledgeable and have experience conducting pre-IND meetings and completing pre-IND meeting packets. A regulatory affairs consultant will know to prioritize questions and to not hide any concerns. The regulatory affairs consultant is familiar with the pitfalls of pre-IND meetings such as inadequate CMC information, insufficient pre-clinical support or an unacceptable clinical trial design. Regardless of whether your pharmaceutical company is a small or large, early FDA interactions and IND consultants are vital to expedite your drug to market faster.

Author Information

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.

BRG is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA regulatory affairs. BRG is a pharmaceutical consulting group focusing on NDA regulatory services, FDA dietary supplements, and IND consulting services.  The opinions and statements in this blog are those of the authors and do not necessarily reflect those of BRG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.

tagging: 510 k premarket notification > FDA establishment registration > Pre IND meeting FDA > USFDA ANDA