The FDA is comprised of multi-disciplinary experts in chemistry, microbiology, pharmacology, toxicology and other various disciplinaries. It is important to keep in mind that these are the experts that will review your pharmaceutical product development report and data. A key to an effective strategy for IND planning is to know the process for submission. The Pre-IND meeting will focus on the design of the initial clinical protocol and more importantly gives a pharmaceutical company the opportunity to discuss their drug in more detail. Items of topic, such as studies and indications should be addressed. It is vital to ask the FDA agents specific questions or request advice for valid concerns. A good IND strategy should include that the basic information needed for an IND application is provided. Nonclinical data should be sufficient to support proposed clinical protocol. Standard exposure data should also be included. The quality, purity and strength of a drug is an absolute requirement for pharmaceutical product development. Batch production and supply is equally important. The pharmaceutical company must be able provide sufficient information to assess if production and supply can be achieved. The FDA will inquire about the applicant’s clinical trial protocol. The number one reason an IND is placed on clinical hold is failure to ensure safety of the subjects or patients during the study. The applicants of the Investigation New Drug application should be knowledgeable with 21 CFR 312. If the applicants are not familiar with the code of federal regulations in reference to IND submissions, it is recommended that they partner with a regulatory consulting firm for expert IND advice. Once an IND is submitted, the FDA will respond in thirty days. The response can include “reasonable safe to proceed” or a “clinical hold”.
A ‘reasonable safe to proceed’ signifies the IND is active. An IND that is active allows the applicant to pursue drug development. New trials can be initiated once protocol is submitted and IRB approval is obtained. At any time, an IND can be placed on a clinical hold. It is important to request meetings if necessary. Meetings have a great impact and the communication between the FDA and the sponsor facilitates a more efficient pharmaceutical product development. Not all meetings are granted. The formulation and the substance of the questions plays a big role of meeting denials. So, make sure the questions are well formed and can be answered by the FDA. The most important meeting during development is the end of phase two. It is held after phase one and phase two studies are completed. During this meeting, any challenges identified during development should be presented so that it may be addressed. A sample label should be provided to ensure that the trial design supports the label.Another key meeting is the Pre-NDA/BLA meeting. The meeting should be requested when all studies that support the claims of safety and efficacy have been completed. A well-planned IND strategy will expedite your NDA/BLA submission. Lack of data, poorly planned studies or any hiccups can waste valuable time and resources.
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 ANDA submissions, 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.