FDA’s Development and Approval Process

Before a new pharmaceutical drug enters the market it must pass rigorous testing and undergo several clinical trials. The Food and Drug Administration’s Center for Drug Evaluation is the main “watchdog” for consumer protection. The increased number of pharmaceuticals recalled from the market for unexpected side effects has brought the standards for a drug’s development and approval into question.

If you or someone you love has suffered because of an unexpected side-effect of the birth control pills Yaz, Yasmin, or Ocella, join the team of victims who are fighting for justice. Contact the Yaz side effect lawyers of Williams Kherkher today by calling 800-761-3187 to discuss your legal options.

Testing

Before new drugs are tested on humans, they are tested in the laboratory. If the drug performs as expected, scientists then test it on animals. Scientists monitor the effects of the drug on animals and then determine whether or not the drug could be potentially helpful for humans. If it passes the animal testing period, it is approved for clinical trials with humans, where it is tested extensively.

Approval

The data from all tests at all stages of trial are gathered and sent to the FDA’s Center for Drug Evaluation for review. While the Center for Drug Evaluation does not conduct any tests, a team of scientists, physicians, statisticians, and pharmacologists review the data and determine whether or not the drug’s benefits outweigh the known risks. If the answer is yes, the FDA approves the drug and it is released on the market for consumers.

Contact Us

Many drugs that have been approved by the FDA have caused unexpected side effects after being released on the market. Some birth control pills, including Yaz, Yasmin, and Ocella have caused women to suffer serious health complications. If you or someone you know has suffered from such side effects, contact the Yaz side effect lawyers of William Kherkher today at 800-761-3187.