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  2. Biologics license application - Wikipedia

    en.wikipedia.org/wiki/Biologics_License_Application

    A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.

  3. New Drug Application - Wikipedia

    en.wikipedia.org/wiki/New_Drug_Application

    Once the application is submitted, the FDA has 60 days to conduct a preliminary review, which assesses whether the NDA is "sufficiently complete to permit a substantive review." If the FDA finds the NDA insufficiently complete, then the FDA rejects the application by sending the applicant a Refuse to File letter, which explains where the ...

  4. Regulation of food and dietary supplements by the U.S. Food ...

    en.wikipedia.org/wiki/Regulation_of_food_and...

    The FDA has the authority to inspect any establishment in which food is manufactured, processed, packed, or held. [16] In searching for contamination, the FDA typically uses organoleptic inspection methods – investigators trained to distinguish contamination and decomposition by sight and smell.

  5. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...

  6. Investigational New Drug - Wikipedia

    en.wikipedia.org/wiki/Investigational_new_drug

    Once an IND application is submitted, the FDA has 30 days to object to the IND or it automatically becomes effective and clinical trials may begin. If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved, as outlined in 21 CFR 312.42.

  7. Abbreviated New Drug Application - Wikipedia

    en.wikipedia.org/wiki/Abbreviated_New_Drug...

    An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an ...

  8. Marketing authorisation - Wikipedia

    en.wikipedia.org/wiki/Marketing_authorisation

    In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.

  9. Complete Response Letter - Wikipedia

    en.wikipedia.org/wiki/Complete_Response_Letter

    In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]