federal_register: 2019-24921

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2019-24921 Pan American Laboratories, LLC, et al.; Proposal To Withdraw Approval of Four New Drug Applications; Opportunity for a Hearing Notice The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of four new drug applications (NDAs) from multiple NDA holders and is announcing an opportunity for the NDA holders to request a hearing on this proposal. The basis for the proposal is that the NDA holders have repeatedly failed to file required annual reports for these NDAs. 2019-11-18 2019 11 https://www.federalregister.gov/documents/2019/11/18/2019-24921/pan-american-laboratories-llc-et-al-proposal-to-withdraw-approval-of-four-new-drug-applications https://www.govinfo.gov/content/pkg/FR-2019-11-18/pdf/2019-24921.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of four new drug applications (NDAs) from multiple NDA holders and is announcing an opportunity for the NDA holders to...

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