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Pproval Process . . . . . . . . . . . . . . . . . . . . . . . . 86 FDA s Medical Device Evaluation Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Safety and Efficacy Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Current Economic Considerations in FDA s Drug and Medical Device Approval Processes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 Potential Applic.
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Cimetidine FAQ
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FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself.
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Information For Step 1: Discovery and Development. Step 2: Preclinical Research. Step 3: Clinical Research. Step 4: FDA Drug Review. Step 5: FDA Post-Market Drug Safety Monitoring.
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The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
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A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.
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The law allows some unapproved prescription drugs to be lawfully marketed if they meet the criteria of generally recognized as safe and effective (GRASE) or grandfathered. However, the agency is not aware of any human prescription drug that is lawfully marketed as grandfathered.
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Drugs undergo laboratory and animal testing to answer basic questions about safety. Drugs are tested on people to make sure they are safe and effective. FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.
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The drug approval process requires four phases, which include preclinical investigation, clinical investigation, review of the new drug application, and postmarketing surveillance. The entire process can take many years and cost millions of dollars in order to approve new drugs that are safe as well as effective.
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FDA reviews the drug's professional labeling and assures appropriate information is communicated to health care professionals and consumers. FDA inspects the facilities where the drug will be manufactured. FDA reviewers will approve the application or issue a response letter.
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