As just summarized, all drugs must submit proven safety and efficacy data before receiving FDA marketing approval. A very time-consuming and expensive process has evolved for demonstrating the safety and efficacy of a new drug . A
"Notice of Claimed Investigational Exemption for a New Drug" (IND) must be filed and approved by the FDA before the substance can be clinically tested on humans. At this time, a multiphase protocol for drug testing must be submitted and approved. If testing proves appropriate, the manufacturer can file a New Drug
Application (NDA). The NDA presents all the testing data gathered on the drug.
The process takes an average of 12 years, and has escalating estimates for -g expenses. When NDA approval has been granted, the new drug can be marketed.
Note that the manufacturer is required to continue to gather clinical information about the drug after marketing it, and to report these data to the FDA. If the man- c ufacturer wishes to modify the delivery system of the drug, an Abbreviated New
Drug Application (ANDA) must be filed and approved.
When an NDA is approved, the FDA determines if the drug should be available via a physician's prescription or made available to the public "over the counter" (OTC: i.e., without a prescription) . If a drug is habit forming, is not safe for self-medication, is potentially hazardous, is new and has not completed its safety testing, or presents uncertainties in its administration, it will be classified as a prescription drug. Medications that do not fall under these restrictions are made available to the public as OTC medications. Many OTC drugs were introduced as prescription medications, then reclassified after confirming results of safety testing and consumer use information had been reviewed. Note that the introduction of new OTC medications into the marketplace requires the manufacturer to complete the IND/NDA approval process.
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