![]() After the label comprehension studies are performed and the most effective Drug Facts Label is developed, self-selection studies are conducted. Self-selection studies assess the ability of consumers to apply drug labeling information to their personal health situation to make correct decisions about whether or not it is appropriate for the consumer to use a drug product.For more information, see the Label Comprehension Studies for Nonprescription Drug Products guidance document. Label comprehension studies assess the extent to which consumers understand the information on nonprescription drug labeling and then apply this information when making drug product use decisions in a hypothetical situation.The consumer behavior studies conducted by a sponsor of nonprescription drug typically include: label comprehension, self-selection, actual use, and human factors studies. One important difference between a drug application for a prescription drug and a nonprescription drug is that consumer behavior studies are often needed to demonstrate that consumers can use the nonprescription drug product safely and effectively without the supervision of a healthcare provider.Ĭonsumer behavior studies are used to evaluate how consumers will use the drug in a nonprescription setting (without the supervision of a health care provider). For more information about the proposed rule, see the webpage FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use.We encourage sponsors to meet with FDA staff to discuss any questions that arise during the development of a nonprescription drug product for which an ACNU will be proposed.Under the proposed rule, when labeling alone is not sufficient to ensure that the consumer can appropriately self-select or appropriately actually use, or both, a drug product correctly in a nonprescription setting, an applicant may submit a drug application proposing an ACNU that a consumer must successfully fulfill to obtain the nonprescription drug product with an ACNU FDA is proposing a rule intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU).For more information on the Rx-to-OTC Switches, see the Prescription-to-Nonprescription (Rx-to-OTC) Switches webpage.However, many nonprescription drugs that have an approved NDA or ANDA were first approved as prescription drugs, before eventually receiving FDA approval to be marketed as nonprescription (an Rx-to-OTC switch). ![]() An NDA may be submitted to market a new drug as nonprescription (direct-to-OTC) without first receiving approval as a prescription drug. ![]() ![]()
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