It pertains to a food or medical product or process that has applied for approval and received it from the Food & Drug Administration. Go to the FDA website for more precise information about it's mission and authority. FDA link: fda.gov
The FDA is the organization primarily involved in the medication/drug approval process.
If being sold as a food, no FDA approval needed. But it will be subject to FDA rules and regulations.
The process for getting FDA approval for a new product depends on the product one wants to sell. If one wants to sell a medicine related product his/her product gets testes in safety and effectiveness area.
the approval of the new drug application by the fda allows for
the question set to public for answer, is a wrong question! it implies that FDA can make an unbiased decision about approving a drug. this assumption, can not hold validity, as FDA is supported by a significant amount, by the pharmaceutical companies. the conflict of interest is already set in, for as long as FDA receives funds from drug companies
Products pending FDA approval, contains the lightning bolt symbol that identifies codes that are being tracked by the AMA to monitor Food and Drug Administration (FDA) status for approval of a drug.
Etizolam is not scheduled in the U.S. nor is it approved by the FDA. This is because the manufacturers have chosen not to go through the very expensive process of acquiring FDA approval for it.
mosapride
Genetically modified salmon, called AguaAdvantage salmon, is waiting for approval from the FDA. (May 2014)
A company can obtain FDA approval for a medical device by submitting a premarket notification (510(k)) or a premarket approval (PMA) application to the FDA. The application must demonstrate that the device is safe and effective for its intended use through clinical data and testing. The FDA will review the application and may request additional information before granting approval.
Answer this question...What is the basis for the U.S. Food and drug Aministration (FDA) approval of pharmaceutical product as safe and effective?