NDA Pre-Submission Activities

Hundreds of New Drug Applications (NDA) are submitted to the FDA every year. The NDA has served as a vehicle to the road of marketing a new drug in the United States. Pharmaceutical companies have relied on NDA consultants for their expertise and to receive NDA regulatory services. Prior to submitting an NDA, applicants must perform pre-submission activities, such as proprietary submission and review, establishment registration and labeler code assignment, and a pre-submission meeting request.

Proprietary Submission and Review

The proprietary name of the product is how consumers and healthcare professionals are able to identify and differentiate between the many products on the market. NDA consultants understand the significance of selecting a name that is not similar to another drug as it could be denied by the FDA due to potential medical errors. Proprietary name submissions should have the following items:

• Primary and alternate proposed proprietary names
• Proprietary name’s pronunciation
• Name derivation
• Intended proprietary name modifier meanings
• Name’s pharmacologic/ therapeutic category
• Draft labeling
• Package Insert (if available)

Establishment Registration & Labeler Code Assignment

Drug manufacturers must electronically register their facility and all drugs actively marketed prior to FDA approving an NDA submission. Since the registration must be updated annually, drug manufacturers frequently opt to contract out those services to an NDA consulting firm. Alternatively, the manufacturer can assign a person in the company to keep up with FDA registrations in order to stay in compliance. Every product has a unique 11-digit national drug code (NDC) number, which consists of the following segments:

• First segment: Identifies the vendor (or labeler), involved in the drug’s manufacture, packaging or distribution
• Second segment: Comprises entity, strength, dosage form and formulation
• Third segment: Indicates package forms and sizes

The FDA utilizes the electronic Drug Registration and Listing System (eDRLS) and establishment registrations to perform post-marketing surveillance, drug recalls, drug shortage preventions and many other FDA activities.

Pre-Submission Meeting Request

The FDA recommends that sponsors or their NDA consultants request a pre-submission meeting for NDAs four to six months prior to the anticipated submission date. Pre-submission meetings are Type B meetings in which the FDA will respond with a confirmation within 21 days from the date of request. The time window for the meeting to occur is within 60 days from the date of request. This meeting is critical and will help the sponsor receive feedback from the FDA prior to their NDA submission. The FDA will be able to answer their questions and the sponsor will be able to hear FDA’s concerns. An NDA consulting firm can help develop a pre-submission packet that will be useful in achieving the sponsor’s objectives.

NDA pre-submission activities can be lengthy and require vast amounts of information and materials from the sponsor. Regulatory consulting firms that provide NDA regulatory services can mitigate the burdens of submitting FDA marketing applications. An NDA application submission fee ranges from one million to two million U.S. dollars. Due to the costs of clinical studies, application fees and product development, many pharmaceutical companies find that teaming up with an NDA consulting firm saves the company valuable resources.

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 483s, cGTPs, 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 an IND consulting firm focusing on ANDAs, INDs, and NDAs.  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.

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