Since a sponsor probably wants to send investigators to medical investigators in many states, it must be exempt from that legal requirement. During the early development of a new drug, the sponsor’s primary goal is to determine whether the product is reasonably safe for early use in humans and if the compound exhibits pharmacological activity that justifies commercial growth. When a product is identified as a potential candidate for further development and used in limited, early-stage clinical studies, the sponsor focuses on gathering the data and information needed to establish that the product does not expose humans to unreasonable risks.
The FDA’s role in the development of a new drug begins, as a supporter of the drug (usually a manufacturer or potential marketer) wants to screen for a new molecule for pharmacological activity and toxicity in animals and test its diagnostic or therapeutic potential in humans. At that time, the molecule becomes legal under the federal Food, Drug and Cosmetic Act and becomes a new drug subject to the specific requirements of the Drug Regulatory System.
There are three IND types:
Investing is submitted by an Investigator IND to a physician who initiates and conducts an investigation, and under whose immediate guidance the investigational drug is administered or distributed. An IND consulting is a physician who proposes to study an unauthorized drug, or a new symptom, or an approved product in a new patient population.
C Emergency application allows the FDA to use a test drug in an emergency that does not allow time for an IND submission following IND regulatory, 21CFR, Sec. 312.23 or sec. 312.20. It is also used for patients who do not meet the criteria of an existing study protocol or if there is no approved study protocol.
There are two IND sections:
• Research (non-commercial)
The IND application should contain information in three broad areas:
• Animal Pharmacology and Toxicology Studies – Data before allowing the initial testing in humans to evaluate whether the product is reasonably safe. Previous experience in drug-related (often foreign use) in humans has been included.
Information Product Information – Information relating to the composition, manufacturer, sustainability and controls used to manufacture the drug product and the drug product. This information is evaluated to ensure that the company can produce and supply adequate medications.
Protocol Ethics and Investigator Information – Detailed protocols for proposed clinical studies to evaluate whether early-stage trials expose subjects to unnecessary risks. Also, information about the qualifications of medical examiners – professionals (usual physicians) overseeing the administration of the test mix – to assess whether they are competent to perform their clinical trial duties. Finally, promising to receive informed consent from the research subjects, review of the study by the Institutional Review Board (IRP), and follow the new drug regimen of investigation.