Current Federal law requires an authorized marketing application for a medication before it is shipped or sold across state lines. Since, in many states, a sponsor would want to sell the investigative drug to clinical investigators, he must obtain an exception from that legal requirement. The IND regulatory is the mechanism by which the sponsor receives the exemption from the FDA legally.
During the early preclinical production of a new drug, the sponsor's primary objective is to assess whether the substance is relatively safe for initial human use and if it exhibits pharmacological activity that supports commercial growth. When a product is established as a viable candidate for further development, the sponsor then focuses on gathering the evidence and information required to determine that the product would not expose humans to unnecessary risk when used in small, early-stage clinical trials.
The FDA's role in developing a new drug starts when the sponsor of the drug having tested the new molecule for pharmacological activity and the potential for acute toxicity in animals, wishes to test its diagnostic or therapeutic potential in humans. The molecule under the Federal Food, Drug, and Cosmetic Act lose its legal status. It becomes a new medication subject to strict standards of the medicines regulatory system.
Guidance documents reflect the current thinking of the Organization on a specific subject. These documents guide the production, content, and evaluation/approval of applications and design, produce, produce, and test approved goods to FDA review staff and applicants/sponsors. They also develop policies to ensure continuity in the Department's regulatory approach and establish protocols for inspection and compliance.
An Investigator IND is sent by a physician who initiates and performs an investigation. Under whose immediate supervision is administered or dispensed the investigational medication. A doctor may send an IND research to suggest testing an unapproved drug, an approved product for a new indication, or a new patient population.
Emergency Usage IND enables the FDA to approve an experimental drug in an emergency that does not allow time to request an IND under 21CFR, Sec. 312.23, or Sec. 312.20. It is often used in patients who do not follow the requirements of an existing study protocol, or where there is no authorized study protocol.
IND is submitted for new drugs showing promise for severe or immediately life-threatening conditions in clinical trials. In contrast, the final clinical study is performed, and the FDA review is completed.
What Does an Ind Regulatory Contain?
Animal Pharmacology and Toxicology Tests-Preclinical evidence allow for evaluating whether the substance is sufficiently secure for initial human testing. Any previous experience with the drug in humans (often for foreign use) is also included.
Manufacturing information-Information about the structure, manufacturer, stability, and controls used to produce the drug material and the drug product. This information is evaluated to ensure the company can produce and supply consistent batches of the drug appropriately.
Detailed guidelines for prospective clinical experiments to determine whether participants would be exposed to unnecessary risks from the initial-phase trials. Also, details on the credentials of clinical investigators - professionals (generally physicians) who supervise the experimental compound administration - determine whether they are competent to perform their clinical trial duties. Finally, it promises to obtain informed consent from the test participants, obtain an institutional review board (IRB) review of the report, and adhere to the investigation's current drug laws.
If the IND is submitted, the sponsor must wait 30 calendar days before starting any clinical trials. During this time, the FDA has an opportunity to review the IND for safety to ensure research topics are not exposed to unnecessary risk.