What happens during the FDA review and approval process of drugs?
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Johns Hopkins Medicine answered:The FDA (Food and Drug Administration) has two main roles when it comes to drug safety. First, it is responsible for the regulation and supervision of new drug development. They require drug manufacturers to abide by a lengthy and rigorous process to ensure the safety and efficacy of the new drug they are intending to bring to market.
Second, they are also responsible for ensuring that all generic drugs meet strict standards of quality, stability, strength, purity and effect before they are approved as a safe and effective alternative to the name brand drug.
The FDA (Food and Drug Administration) has two main roles when it comes to drug safety. First, it is responsible for the regulation and supervision of new drug development. They require drug manufacturers to abide by a lengthy and rigorous process... More -
PhRMA answered:In this final stage, the FDA scientists review all the results from all the studies carried out over the years and determine if they show that the medicine is safe and effective enough to be approved.
Depending on the medicine or disease in question, the FDA sometimes convenes an Advisory Committee meeting. These independent panels of experts, appointed by the FDA, consider data presented by company representatives and FDA reviewers. Committees then vote on whether the FDA should approve an application, and under what conditions. The FDA is not required to follow the recommendations of the advisory committees, but they often do.
If the medicine is approved, or "cleared for marketing," it becomes available for physicians and patients.
It took an average of 16.9 months for the FDA to review each medicine it approved in 2003. The proportion of rejected applications has remained constant over the years at about 10% to 15%.
In this final stage, the FDA scientists review all the results from all the studies carried out over the years and determine if they show that the medicine is safe and effective enough to be approved. Depending on the medicine or disease in... More
