Ask a Question
or
Create a Poll
  1. Home /
  2. Questions /
  3. Places
  4. / North America
  5. / United States
  6. / U.S. Politics
  7. / US Government Organizations

by Thommy on March 4th, 2005

Thommy

Question

Help answer this question below.

What is the process for the FDA approving a new drug? How is this process influenced by external factors (such as drug companies)?

Share:
Other

Answers. 1 helpful answer below.

  • by Jillifish on March 6th, 2005

    Jillifish

    STAGES of DRUG DEVELOPMENT and REVIEW by the FDA's CDER

    1. INVESTIGATIONAL NEW DRUG APPLICATION (IND)
    The FDA first enters the picture when a drug sponsor submits an IND to the agency. Sponsors--companies, research institutions, and other organizations that take responsibility for marketing a drug--must show the FDA results of pre-clinical testing they've done in laboratory animals and what they propose to do for human testing. At this stage, the FDA decides whether it is reasonably safe to move forward with testing the drug on humans.

    2. CLINICAL TRIALS
    Drug studies in humans can begin only after an IND is reviewed by the FDA and a local institutional review board (IRB). The board is a panel of scientists and non-scientists in hospitals and research institutions that oversees clinical research.

    IRBs approve the clinical trial protocols, which describe the type of people who may participate in the clinical trial, the schedule of tests and procedures, the medications and dosages to be studied, the length of the study, the study's objectives, and other details. IRBs make sure the study is acceptable, that participants have given consent and are fully informed of their risks, and that researchers take appropriate steps to protect patients from harm.

    Phase 1 studies are usually conducted in healthy volunteers. The goal here is to determine what the drug's most frequent side effects are and, often, how the drug is metabolized and excreted. The number of subjects typically ranges from 20 to 80.

    Phase 2 studies begin if Phase 1 studies don't reveal unacceptable toxicity. While the emphasis in Phase 1 is on safety, the emphasis in Phase 2 is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. For controlled trials, patients receiving the drug are compared with similar patients receiving a different treatment--usually a placebo or a different drug. Safety continues to be evaluated, and short-term side effects are studied. Typically, the number of subjects in Phase 2 studies ranges from a few dozen to about 300.

    Phase 3 studies begin if evidence of effectiveness is shown in Phase 2. These studies gather more information about safety and effectiveness, studying different populations and different dosages and using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people.

    Phase 4 studies occur after a drug is approved. They may explore such areas as new uses or new populations, long-term effects, and how participants respond to different dosages.

    3. NEW DRUG APPLICATION (NDA)
    This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.
    (source FDA http://www.fda.gov/fdac/features/2002/402_drug.html)

    As to how this process can be influenced, I suppose that drug companies could bump their drugs further up the line of NDAs, effectively decreasing the time it takes to release the drug for sale. Alternatively, a competing drug could be moved further down the line. But that is just speculation. Drugs absolutely *must* go through the various trial phases, so they are not open for comprimise.

    • Like
    • Report

    No comments. Post one | Permalink

Want to attach an image to your answer? Click here.

Did this answer your question? If not, then ask a new question or create a poll.

More Questions. Additional questions in this category.

You're reading What is the process for the FDA approving a new drug? How is this process influenced by external factors (such as drug companies)?

Follow us on Facebook!

Related Ads

Related Questions

Professionally Researched

ANSWERBAG BUZZ

Steps in approving a new drug in the u s
Can office 2007 be loaded onto more than 1 pc
Developing and approving a new drugs in the usa
Fda process for approving new drugs
Steps in developing and approving a new drug in us

Answerbag

a Demand Media company