Discover common mistakes in IND/IMPD submissions and how to avoid them. Learn about preclinical data, clinical protocols, regulatory compliance, and more.
We dissect these submissions to reveal common mistakes and how to avoid them.
The Importance of IND/IMPD Submissions:
Trusted Data:
IND and IMPD applications require an integrative database of different types of evidence such as preclinical data, clinical data, manufacturing information and regulatory documents. Not providing any key aspect can result in certain delays and hindrances from the regulatory review side.
Regulatory Compliance:
Regulatory guidelines must be strictly followed. Missing a regulatory requirement either by way of format, content or timing will lead to rejection or delays in getting approval from regulators.
How to Avoid Common Pitfalls in IND/IMPD Submissions:
Preclinical Data Deficiency:
A deficit of preclinical data can discredit claims made about the safety and efficacy of the investigational product. Conduct extensive preclinical studies, such as pharmacology and toxicology that are required based on regulatory expectations. Create a detailed report of the data to support strong arguments for the safety and effectiveness of the investigational product.
Incomplete Clinical Trial Protocols:
Incomplete or missing clinical trial protocols can prevent proper evaluation by regulators. Write comprehensive clinical study protocols, documenting the protocol background and rationale, objectives, design, endpoints, statistical methodology and sample size calculation wherever applicable and inclusion or exclusion criteria. Enable protocols to be in line with regulatory guidelines and industry standards.
Insufficient Manufacturing Information:
Lack of information about the process used to manufacture a given product can be a red flag when it comes to consistency, and overall quality. Include extensive manufacturing information from How to Make, Process Controls, Specifications, Comply with Good Manufacturing Practice (GMP) standards and demonstrate actions you have taken to ensure the quality and consistency of the products.
Regulatory Strategy is Weak:
A weak regulatory strategy can result in miscommunication or disagreements with regulatory authorities. Create a strong regulatory strategy linking it to the development plan of the product. Communicate this strategy clearly in the submission or pre-emptively answer questions.
Missing Pharmacovigilance Plans:
If you fail to include a full pharmacovigilance plan, this may be an indication to regulators that the sponsor is not interested in monitoring safety for their product. Define a pharmacovigilance plan for safety data collection, analysis, and reporting. Show how the sponsor is committed during the entire lifecycle of the product to continue monitoring safety.
Conclusion: IND/IMPD submission pitfalls and how to avoid them:
A strategic imperative for successful regulatory approval– If we can overcome potential pitfalls before the start of trials, it helps to have a better chance with regulators and ensuring that innovation or putting something new into action can happen faster, which means more therapies that may make a difference for patients.
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