Лента новостей - FDA.GOV

  • Animal Rule Information
    Links to information about the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible
  • CDER Small Business & Industry Assistance (SBIA)
    This site visit program is designed to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as the challenges that impact a drug’s developmental program and commercial life cycle. The goal of these visits is to provide OPQ staff exposure to the drug development and manufacturing processes in industry; therefore, a tour of pharmaceutical company facilities in operational status is an integral part of the experience.
  • Webinar: The FDA Study Data Technical Conformance Guide v4.4 - Nov 22, 2019 - 11/22/2019 - 11/22/2019
    The Study Data TGC provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog. The TCG supplements the guidance for industry
  • Phonetic and Orthographic Computer Analysis (POCA) Program
    Use CDER’s Phonetic and Orthographic Computer Analysis (POCA) to help identify drug and biologic names that are phonetically and/or orthographically similar to one another. In conducting proprietary name reviews, the Division of Medication Error Prevention and Analysis (DMEPA) evaluates the orthographic and phonetic similarity of a proposed proprietary name to other proprietary or established names using the POCA software program. POCA uses algorithms to assess the similarity of names when spoken or written and assigns a percent similarity score to a given name pair.
  • What's New Related to Drugs
    Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

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