DEFINITION of 'Investigational New Drug (IND)'

An Investigational New Drug (IND) application is the first step in the drug review process by the U.S. Food and Drug Administration (FDA). The application is submitted by the company responsible for developing the drug (the sponsor) to the FDA.

BREAKING DOWN 'Investigational New Drug (IND)'

Investigational New Drugs (INDs) fall into two categories:

1. Commercial - submitted mainly by companies seeking marketing approval for a new drug

2. Research (non-commercial) - the majority of INDs are filed for non-commercial research and are of three main types – Investigator IND, Emergency Use IND, and Treatment IND.

The IND application contains information in three broad areas –

  • Animal pharmacology and toxicology studies: contains the preclinical studies needed to establish whether the drug is reasonably safe for initial tests in humans, as well as any previous experience involving human use of the drug (such as in foreign markets).
  • Manufacturer information: includes information to ensure that the company can manufacture sufficient batches of the drug.
  • Clinical Protocols and Investigator Information: contains protocols to determine if the initial trials will expose human subjects to needless risks, and includes qualifications of the clinical investigators who will oversee administration of the compound.

An IND is not an application for marketing approval. It is the avenue through which the sponsor gets from the Food & Drug Administration (FDA) an exemption to the Federal law that prohibits an unapproved drug from being transported across state borders. This exemption is required since in most cases the sponsor will need to ship the investigational drug to investigators in other states. To obtain the exemption, the sponsor must submit sufficient data through the IND, documenting the safety of the drug for use in human testing.

In effect, an IND is submitted after the sponsor has determined through animal studies that the proposed drug is reasonably safe for initial use in humans, and that it shows sufficient promise as a treatment to justify commercial development. The FDA reviews the IND application and decides whether it is safe for the company to progress to the next stage, i.e. clinical trials, wherein the drug is tested in humans. The sponsor has to wait for 30 calendar days after submitting the IND before commencing any clinical trials. Since it can cost hundreds of millions of dollars – and many years – to undertake the clinical trials necessary to bring a new drug to market, the IND application signifies that the sponsor is willing to make this huge investment. As such, investor reaction to an IND application – the first step in a long and arduous process for drug approval – filed by a company is typically neutral.

RELATED TERMS
  1. New Drug Application (NDA)

    The New Drug Application (NDA) is the formal final step taken ...
  2. Drug

    A drug is a substance that cures, treats, prevents or reduces ...
  3. Orange Book

    The Orange Book is a list of drugs that the U.S. Food and Drug ...
  4. Bioequivalence

    Bioequivalence represents the similarity between two drugs that ...
  5. Pharmacology

    Pharmacology is the study of drugs and how they affect people, ...
  6. Blockbuster Drug

    A blockbuster drug is an extremely popular drug that generates ...
Related Articles
  1. Investing

    It's No Accident That Drugs Are Expensive

    Branded drugs are expensive in large part because it's expensive and risky to develop them
  2. Investing

    Drug Approvals Fell to Six-Year Low in 2016

    New drug approvals dropped to modest levels in 2016 following highs in 2014 and 2015.
  3. Investing

    Evaluating Pharmaceutical Companies

    Learn how to find a healthy pharmaceutical investment in a market full of weak drugs.
  4. Investing

    Could the FDA Hiring Freeze Make Drugs More Expensive?

    Drug approvals by the resource-constrained FDA will take longer, leading to longer waits for the approval of cheaper alternatives.
  5. Insights

    The Industry Handbook: Pharma Industry

    Learn about the pharmaceutical industry and discover the forces that influence this highly profitable and dynamic sector.
  6. Insurance

    The Cancer (and Other Drug) Shortage

    Your doctor may not tell you, but even in the U.S., life-saving drugs can be in short supply. Here's what to know and do.
  7. Investing

    Drug Industry Launches TV Ads to Repair Image

    Lobbyists have rolled out TV ads to repair the drug industry's damaged public image.
  8. Insights

    Why Are Prescription Drug Prices So High?

    Expensive drugs that don’t have affordable alternatives or generic equivalents are a serious concern today. So why are prescription drug prices so high?
  9. Investing

    Drug Wholesalers Feel Pricing Heat (MCK, ABC)

    Drug wholesalers are feeling a trickle-down pressure from the increased price scrutiny being paid to drug manufacturers.
  10. Investing

    High Prescription Drug Prices Draws More Scrutiny

    Two industry leaders suggest that government-run drug companies could limit price hikes.
RELATED FAQS
  1. Who are Pfizer's (PFE) main competitors?

    Learn about Pfizer's place in the pharmaceutical industry, and find out which major drug manufacturers are among its main ... Read Answer >>
  2. What is the average price-to-earnings ratio in the drugs sector?

    Learn what the average price-to-earnings ratio is for companies operating in the drugs sector and why this metric is important ... Read Answer >>
  3. What's the difference between credit reports and investigative consumer reports?

    Learn about the major differences between two types of risk-evaluation reports: consumer credit reports and investigative ... Read Answer >>
  4. What is human capital and how is it used?

    Learn about the concept of human capital, how it is developed and why it is important for businesses to protect their human ... Read Answer >>
  5. What is the relationship between human capital and economic growth?

    Learn what human capital and economic growth are, how human capital is related to economic growth and see examples of the ... Read Answer >>
Trading Center