Investigational New Drug (IND)
Categories: Entrepreneur
Broadly speaking, an investigational new drug is just what its name suggests: a new medicine currently going through the testing process. It's new. It's a drug. And it's under investigation.
In other words, a company has developed a compound that it hopes will cure (or at least treat) some disease. But it still needs to run tests to make sure it works...and that it doesn't make people grow an additional set of genitals in their armpits, or whatever.
The term "Investigational New Drug" has a specific, administrative connotation as well. It represents a technical designation used by the FDA, the top drug regulator in the U.S.
When a drug developer has a new product it wants to bring to market, it has to run through a series of exhaustive tests. This process involves working with the FDA to make sure that the medicine actually does something to help people get better, and that the drug is safe enough for humans to take (no additional sets of armpit genitals, etc.).
A key step in the process is filing the Investigational New Drug (IND) Application. It kick-starts the the testing process.
From there, the company jumps through all the prescribed (pun intended) hoops in order to get the drug approved. The testing can take years, with the product passing through a series of trials with increasing numbers of people involved, and increasing requirements for both safety and efficacy.