federal_register: E9-4372

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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
E9-4372 Draft Guidance for Industry on the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." This draft guidance is one of a series of guidance documents intended to assist applicants in complying with new FDA regulations on the content and format of labeling for human prescription drug and biological products. The draft guidance describes the recommended information to include in the Clinical pharmacology section of labeling that pertains to the safe and effective use of human prescription drug and biological products. 2009-03-03 2009 3 https://www.federalregister.gov/documents/2009/03/03/E9-4372/draft-guidance-for-industry-on-the-clinical-pharmacology-section-of-labeling-for-human-prescription https://www.govinfo.gov/content/pkg/FR-2009-03-03/pdf/E9-4372.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." This draft guidance is...  

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