İlaçlar
The United States FDA regulates products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body of man or other animals. Registrar Corp provides Registration, Update, and Renewal assistance for U.S. and Non-U.S. companies in the Drug industry.
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Active Pharmaceutical Ingredients (API)
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Any substance or mixture of substances (starting materials) intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug becomes an active ingredient of the drug product.
API Examples
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Over the Counter Drugs (OTC)
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A human drug that is safe and effective for use without prescription by a licensed medical practitioner.
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Prescription Drugs
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A human drug that is not safe for use except under the supervision of licensed medical practitioner.
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Homeopathic Drugs
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The U.S. Congress passed a law in 1938 declaring that homeopathic remedies are to be regulated by the FDA in the same manner as nonprescription, over-the-counter (OTC) drugs, which means that they can be purchased without a physician's prescription. Homeopathic remedies are required to meet certain legal standards for strength, quality, purity, and packaging.
Homeopathic Examples
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Drug Master File (DMF)
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A DMF is a submission to FDA that may be used in support of premarket submissions to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
DMF Examples
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Applicable U.S. Regulations:
FDA Regulation: 21 C.F.R. Part 207 and 314.420
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