After any of new drug or medical device is approved by US FDA , it is required that the drug and the medical device to be reviewed for its safety and efficacy even after it is released or approved by FDA , hence new drug or medical devices are monitored for any of the adverse effects which may not be reflected in the actual clinical trials up to last stage , due to any reason.
US FDA approves a drug after through review of the filed technical documents, after the outcomes are found satisfactory , and grants approval with the condition of post market surveillance to ascertain that the new drug or the medical device approved is really as safe and effective as it was found in the clinical trials.
Following are the CFR'S pertaining to post market surveillance
21CFR310.305 Records and reports concerning adverse drug experiences of marketed prescription drugs for human use without approved new drug applications
21CFR312.32 Investigational New Drug Safety Reports
21CFR314.80 Post marketing reporting of adverse drug experiences
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Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definations.
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