B1 archiver review12/29/2023 The report is also required to contain a brief description of actions the applicant has taken or intends to take as a result of this new information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study. A brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product. The report is required to contain in the order listed: Each annual report is required to be accompanied by a completed transmittal Form FDA 2252 (Transmittal of Periodic Reports for Drugs for Human Use), and must include all the information required under this section that the applicant received or otherwise obtained during the annual reporting interval that ends on the U.S. approval of the application, two copies of the report to the FDA division responsible for reviewing the application. The applicant shall submit each year within 60 days of the anniversary date of U.S. (ii) Information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specification established for it in the application. (i) Information concerning any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article. The report and its mailing cover should be plainly marked: "NDA - Field Alert Report." The information may be provided by telephone or other rapid communication means, with prompt written followup. The applicant shall submit information of the following kinds about distributed drug products and articles to the FDA district office that is responsible for the facility involved within 3 working days of receipt by the applicant. The applicant shall submit to the Food and Drug Administration at the specified times two copies of the following reports: Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act. PART 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG The information on this page is current as of Oct 17, 2023.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
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