Investigational New Drug

Definition

An Investigational New Drug (IND) is a pharmaceutical product that is under investigation for human use and has not yet been approved for marketing by regulatory authorities. It is the first step in the drug development process, allowing for the clinical evaluation of a new drug's safety and efficacy before it can be submitted for marketing approval.

5 Must Know Facts For Your Next Test

1. The IND process allows the drug manufacturer to ship the experimental drug across state lines for clinical trials, without violating the Federal Food, Drug, and Cosmetic Act.
2. The IND application must include information about the drug's composition, manufacturing, pharmacology, and toxicology, as well as a detailed clinical trial protocol.
3. The FDA has 30 days to review the IND application and raise any concerns before the clinical trials can begin.
4. Successful completion of the IND process and clinical trials is a prerequisite for a drug manufacturer to submit a New Drug Application (NDA) for marketing approval.
5. The IND process is a crucial step in ensuring the safety and efficacy of new drugs before they can be made available to the general public.

Review Questions

• Explain the purpose of the Investigational New Drug (IND) process in the context of drug development and approval.
  • The Investigational New Drug (IND) process is the first step in the drug development and approval pathway. It allows drug manufacturers to ship and administer an experimental drug across state lines for the purpose of conducting clinical trials. The IND application must include detailed information about the drug's composition, manufacturing, pharmacology, and toxicology, as well as a clinical trial protocol. This process ensures that the safety and efficacy of the new drug can be thoroughly evaluated before it can be submitted for marketing approval through the New Drug Application (NDA) process. The IND is a critical step in protecting public health by ensuring that new drugs meet the necessary standards before being made available to the general population.
• Describe the role of the Investigational Review Board (IRB) in the Investigational New Drug (IND) process.
  • The Investigational Review Board (IRB) plays a crucial role in the Investigational New Drug (IND) process. The IRB is a committee that is formally designated to review and monitor biomedical research involving human subjects. The IRB's primary responsibility is to protect the rights and welfare of the participants in clinical trials. They review the IND application, including the clinical trial protocol, to ensure that the risks to participants are minimized and that the potential benefits outweigh the risks. The IRB must approve the clinical trial protocol before the IND can proceed, and they continue to monitor the trial throughout its duration to ensure ongoing compliance with ethical and safety standards.
• Analyze the relationship between the Investigational New Drug (IND) process and the New Drug Application (NDA) in the context of drug development and approval.
  • The Investigational New Drug (IND) process and the New Drug Application (NDA) are closely linked in the drug development and approval pathway. The successful completion of the IND process, including the successful completion of clinical trials, is a prerequisite for a drug manufacturer to submit an NDA for marketing approval. The IND process allows for the initial evaluation of a new drug's safety and efficacy, while the NDA process involves a comprehensive review of all the data collected during the IND process and clinical trials. The NDA submission must demonstrate that the new drug is safe and effective for its intended use, and that its benefits outweigh its risks. The IND and NDA processes work together to ensure that new drugs meet the necessary standards for approval and are safe for public use.

Related terms

New Drug Application (NDA): The New Drug Application (NDA) is the formal process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.

Investigational Review Board (IRB): An Investigational Review Board (IRB) is a committee that has been formally designated to review and monitor biomedical research involving human subjects, with the aim of protecting the rights and welfare of the participants.

Orphan Drug: An Orphan Drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.