federal_register: 2013-26491

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2013-26491 Smith Miller and Patch Inc. et al.; Proposal to Withdraw Approval of 14 New Drug Applications; Opportunity for a Hearing Notice The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the Agency's proposal to withdraw approval of 14 new drug applications (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications. 2013-11-06 2013 11 https://www.federalregister.gov/documents/2013/11/06/2013-26491/smith-miller-and-patch-inc-et-al-proposal-to-withdraw-approval-of-14-new-drug-applications https://www.govinfo.gov/content/pkg/FR-2013-11-06/pdf/2013-26491.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the Agency's proposal to withdraw approval of 14 new drug applications (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have...  

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