Investigational New Drug (IND) is the application done by the various pharmaceutical companies to the FDA (Food and Drug Administration) for obtaining the approval to apply the treatment for human clinical trials as a part of clinical development. Pre-IND criteria fulfillment is the crucial stage in clinical development, and it requires strong strategic planning. Submitting the Investigational New Drug (IND) application is the backbone of new drug development.
Pre-IND application process
IND submission needs careful planning to get FDA regulatory approval. The FDA review panel resolves the queries through pre-IND meetings with the drug development companies pertaining to their specific products. The relevant discussion owing to the new clinical development of the drug in the Pre-Investigational New Drug Application (IND) Consultation Program needs to be cleared specifically in detail. The FDA’s feedback on clinical trial design or regulatory issues is beneficial for future drug development and helps pharmaceutical companies to submit the IND application.
Key Decisions in the Pre-IND Process
The primary goal of clinical development of a drug should be introducing a safe product for long-run use by the human. If the new drug reaches pharmacological stages and passes through the approval for commercial production, the sponsor should make the primary objective to collect necessary data to confirm that the product is not creating any potential risk to humans.
Type of IND adopted in clinical development of drug
- Investigator IND is a type of IND where a physician conducts and investigates both on his own and submits a research IND for approval of the drug.
- Emergency Use IND is authorized by the FDA for the experimental purpose of a drug in an emergency situation. It is applicable for patients who do not fall under any existing study protocol, or it may be the reason that there is no existence of any approved protocol.
- Treatment IND application is for experimental drugs that are developed for clinical testing of life-threatening diseases. However, final approval and review are done by the FDA.
The IND application process must have the manufacturing information with preclinical data showing that the product is reasonably safe to use. Detailed protocols with proposed studies are mandatory for clinical development of drugs. Organizations like Allucent help guide drug developers step by step through the complicated approval process.
Frequently Asked Questions
What is the minimum waiting period for starting clinical trials after an IND is submitted?
There is a minimum waiting period of 30 calendar days that a sponsor should wait for FDA review and confirmation that the new drug will not have any potential risk to humans.
What are the two main IND categories?
IND has two major categories: commercial and research (non-commercial).
What information must an IND contain to get approval from the FDA?
An IND application process must contain animal pharmacology or toxicology studies, manufacturing information, clinical protocols, and investigator information.
How to submit IND content?
The IND should be submitted electronically in CTD format. It should have modules 1 to 5 for compliance with the FDA guidelines.
What are the laws and regulations maintained by the FDA for consumer health?
The Federal Food, Drug, and Cosmetic Act is followed by the FDA for approving new drug as safe and effective made up with appropriate ingredients.
