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What is IND in pharma?

What is IND in pharma?

An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

What is NDA and IND?

The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

What is the purpose of IND?

The stated purpose of an IND is “to ensure that subjects will not face undue risk of harm” in a clinical investigation that involves the use of a drug. Hence, to authorize a drug study in humans, the FDA requires sufficient information to assess the safety of the intended research study.

What happens after IND approval?

Once an IND application is in effect, a drug manufacturer may ship the investigational new drug to the investigator(s) named in the application. An investigator may not administer an investigational new drug to human subjects until the IND application goes into effect.

Is IND and NDA same?

The Investigational New Drug (IND) application falls into the first category, while the New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) fall into the second category.

When IND is filed?

Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.

What comes first IND or NDA?

Is IND public information?

§ 312.130 Availability for public disclosure of data and information in an IND. (a) The existence of an investigational new drug application will not be disclosed by FDA unless it has previously been publicly disclosed or acknowledged.

How long does IND approval take?

The IND must make a decision on your application for review within 6 weeks. The decision period of 6 weeks always starts on the last day on which you are able to submit an application for review. Even if you submit the application for review earlier. This decision period can be extended by a maximum of 6 weeks.

What are the different types of IND?

There are three IND types: An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.