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WORLD OF GENERIC DRUGS MODULE

  1. Could you give a detailed explanation about how FDA guarantees the consistency between reviews of multiple applications for the same drug, and the fairness in the timing of reviews?
    1. The short answer is FDA takes criteria from the new drug application. All generic companies are locked into this one set of parameters based on the brand product.

      There may be cases when five companies come in on the same day. People sometimes camp in FDA's parking lot, waiting to submit an application. But when applications come in on the same day, FDA has rules that the first one in the door is going to be the first one reviewed.

  2. Does FDA audit API manufacturing facilities as part of the approval process if the active ingredient is coming from a facility outside the United States but the product is to be marketed in the United States?
    1. Brand or generic, FDA wants to know every aspect of every company, and every upstream supplier of the active ingredient and inactive ingredients. Brand or generic, FDA is going to do its review and inspect facilities to make sure information is available to facilitate the overall approval decision. If the company has a bad API, the product is not going to get approved.
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Topic: page 7 of 8 (Lesson: page 37 of 39)