federal_register: 2010-29799

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2010-29799 Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Hospital- Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment." The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drugs for the treatment of hospital- acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). The science of clinical trial design and our understanding of these diseases have advanced in recent years, and this draft guidance, when finalized, will inform sponsors of the recommendations for clinical development. 2010-11-29 2010 11 https://www.federalregister.gov/documents/2010/11/29/2010-29799/draft-guidance-for-industry-on-hospital-acquired-bacterial-pneumonia-and-ventilator-associated https://www.govinfo.gov/content/pkg/FR-2010-11-29/pdf/2010-29799.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Hospital- Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment." The purpose of this...

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