![]() Pertinent marketing experiences that may influence a determination as to the safety of the finished drug product.Ĥ. Pertinent marketing experiences that may influence a determination as to the safety of combinations of the individual active components.Ĥ. Pertinent medical and scientific literature.Ĥ. Pertinent marketing experiences that may influence a determination as to the safety of each individual active component.ĥ. Identify expected or frequently reported side effects.Ĥ. Combinations of the individual active components.ģ. Partially controlled or uncontrolled studies.ī. A statement setting forth the quantities of active ingredients of the drug.Ģ. Label(s) and all labeling (preferably mounted and filed with the other data - facsimile labeling is acceptable in lieu of actual container labeling). All submissions must be in the following format: When requested, abbreviated submissions should be sent. To be considered, eight copies of the data and/or views on any marketed drug within the class must be submitted, preferably bound, indexed, and on standard sized paper (approximately 8 1⁄ 2 × 11 inches). Thirty days thereafter such data and information shall be made publicly available and may be viewed at the office of the Division of Dockets Management of the Food and Drug Administration, except to the extent that the person submitting it demonstrates that it still falls within the confidentiality provisions of one or more of those statutes. 331(j), shall be handled by the advisory review panel and the Food and Drug Administration as confidential until publication of a proposed monograph and the full report(s) of the panel or until the Commissioner places the panel's recommendations on public display at the office of the Division of Dockets Management. Data and information submitted pursuant to a published notice, and falling within the confidentiality provisions of 18 U.S.C. The Commissioner will publish a notice in the Federal Register requesting interested persons to submit, for review and evaluation by an advisory review panel, published and unpublished data and information pertinent to a designated category of OTC drugs. ![]() Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions. Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).Ĭonditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.Īdditional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded. NDA deviations from applicable monograph. Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs. Imprinting of solid oral dosage form drug products. General conditions for general recognition as safe, effective and not misbranded. Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded
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