federal_register: 2014-02765

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2014-02765 Annual Reports for Approved Premarket Approval Applications, Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Annual Reports for Approved Premarket Approval Applications (PMA)." The purpose of this guidance is to describe the information required to be included in an annual report for an approved PMA, additional information requirements that may be imposed by an approval order, and FDA's recommendations for the level of detail the applicant should provide in the annual report. It also identifies the steps FDA staff generally takes when reviewing annual reports, the resources available to assist staff in their reviews, and the regulatory actions they may recommend after reviewing annual reports. 2014-02-10 2014 2 https://www.federalregister.gov/documents/2014/02/10/2014-02765/annual-reports-for-approved-premarket-approval-applications-guidance-for-industry-and-food-and-drug https://www.govinfo.gov/content/pkg/FR-2014-02-10/pdf/2014-02765.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Annual Reports for Approved Premarket Approval Applications (PMA)." The purpose of this guidance is to describe the information required to be included in...

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