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  3. Health Sciences Entrepreneurs
  4. Regulatory Requirements
  • Get Started
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  • Regulatory Requirements
  • Going global

Health Sciences Entrepreneurs : Regulatory Requirements

Resources

  • FDA Center for Drug Evaluation and Research (CDER)
    U.S. Agency involved in new drug development and review, generic drug review, over-the-counter drug review, and post drug approval activities.
  • Drugs@FDA
    Search by drug name, active ingredient, or application number to receive a drug details report including therapeutic equivalents and approval history
  • Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
    Also includes patent and exclusivity information.
  • Drug and Biological Approval Reports
    Listing of approved New Drug Applications (NDAs), Biological Licensing Applications (BLAs), New Molecular Entity Drugs (NMEs), and New Biologics. Also includes statistics on approval times and approval rates.
  • What's New Related to Drugs?
    Includes the most recent drug approvals.
  • European Medicines Agency (EMEA)
    European drug regulatory agency.
  • MedTech Insight (Citeline)
    • Northeastern login or email required
    Medtech Insight features articles on medical technologies in surgical, orthopedic, cardiovascular. medical device, diagnostic and biotech sectors. Also includes The Gray Sheet. For access, please click 'Sign In' and use your Northeastern email and password.
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  • Last Updated: Jun 3, 2025 10:52 AM
  • URL: https://subjectguides.lib.neu.edu/healthsciencesentrepreneurs
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Subjects: Business and Management, Entrepreneurship, Health Sciences and Public Health
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