The control and regulation of a new drug are based upon the New Drug Application (NDA)since decades. The practice is followed since 1938. NDA is thus a formal step taken by the drug manufacturer, wherein it asks for an approval from the Food and Drug Administration (FDA) to market the new drug. It’s a common practice in the United States especially.
During the manufacturing process of new drug animal and human clinical trials are carried out. The trial data becomes the Investigational New Drug (IND) and is one of the crucial parts of NDA.
The role of NDA application is to provide the FDA with sufficient information to permit FDA reviewer to reach a final decision. The FDA takes a decision based on the following:
- Safety and effectiveness of the drug. It is done in a manner so as the benefits of it should outweigh the risks if any.
- Labeling of the drug should be appropriate as per the labeling standards.
- The process of manufacturing the drug and controls should be optimum. They should be as such to maintain the drug’s quality, its identity, its strength, its quality, and its purity.
- The document should explain the clinical tests, the drug chemical composition, results of animal studies, the impact of the drug inside the body, and the processing and packaging process.
Investigation of a new drug
IND is the prime part of new drug application process. For the legal testing, the drug on human subjects the drug must obtain an Investigational New Drug (IND) designation first from the FDA. IND is a combination in vivo and invitro data that suggests human safety. It can be of three types:
- Investigator IND: This data is submitted by a physician who conducts the drug investigation. It’s under his guidance the drug is administered. A physician has to submit a research IND report after carrying out the investigation. The physician has the right to approve or unapproved a drug for a new indication or in a new patient population.
- Emergency Use IND: It allows the FDA to permit the use of the experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR. It is generally used for the patients who do not encounter the criterion for the pre-existing study protocol or if approved protocol is not valid.
- Treatment IND: It is meant for the experimental drugs that promise and cure in the clinical trial for serious life-threatening conditions. It is done when the final clinical trials are approved and left for FDA review.
The regulations of the IND application process are as follows:
- 21CFR Part 312: Investigational New Drug Application
- 21CFR Part 314: INDA and NDA Applications for FDA Approval for marketing a new drug
- 21CFR Part 316: Orphan Drugs
- 21CFR Part 58: Good Lab Practice for Nonclinical Laboratory [Animal] Studies
- 21CFR Part 50: Protection of Human Subjects
- 21CFR Part 56: Institutional Review Boards
- 21CFR Part 201: Drug Labelling
- 21CFR Part 54: Financial Disclosure by Clinical Investigators