Tuesday, April 27, 2010

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posted by edanjou at 9:29 AM 0 comments

Thursday, April 8, 2010

What is the FDA Drug Approval Process?

While no drug is completely without side effects, the Food and Drug Administration (FDA) takes every drug through a long, complex process of approval before allowing it to be made available for general use. This approval process is meant to ensure that the benefits of a drug significantly outweigh the risks, and that the drug truly is effective for the condition it is meant to treat.

The Process of Approval
Before it can be approved for general use, the drug is subjected to a variety of trials, from laboratory trials to animal testing to long-term testing on humans under strict FDA oversight. The full approval process can take as long as eight to twelve years.

FDA testing occurs in three phases:

  • Phase 1-the drug is tested on healthy volunteers to determine overall safety and various side effects
  • Phase 2-the drug is tested on a few hundred patient volunteers to determine its effectiveness
  • Phase 3-the drug moves into a large-scale trial on several hundred to several thousand patients to further determine results and adverse effects


Once this testing is completed, the FDA still has to make a final approval on the drug. This final review alone can take over two years.

Dangerous Drugs
In spite of the rigorous testing, some drugs that receive approval later prove to have dangerous and even deadly side effects. Often this is because, even in the last phase of testing, the number of people tested represents only a tiny percentage of the overall population.

If you have suffered severe side effects from any kind of medication, please contact a pharmaceutical injury attorney near you for more information on how you might be able to receive compensation.

posted by Erica at 8:21 AM 0 comments

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