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  • Recent Posts
    • The OTC Fee Fallout: Are Hundreds of Companies Ignoring FDA’s User Fee Requirements? July 3, 2025
    • HP&M Seeks Experienced Regulatory Expert July 2, 2025
    • Controlled Substance Reporting Isn’t Just for DEA Anymore July 1, 2025
    • The RFD Process: Time for Reform? June 30, 2025
    • New Report on Patent Litigation Settlements Says that they are Critically Necessary to Ensure Prompt Generic and Biosimilar Market Entry June 26, 2025
  • Trackers
    • 180-Day Exclusivity Tracker
    • FDA Citizen Petition Tracker
    • REMS Tracker (Historical – Not Recently Updated)
    • FDA Legislation Tracker

  • Orange Book Archives

     

    ANDA Paragraph IV Patent Certifications List Archives

  • Scorecards
    • Generic Drug Labeling Carve-Out Scorecard
    • Biosimilars State Legislation Scorecard (Historical – Not Recently Updated) 
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    • Bloomberg BNA Health Care Blog
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