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  • Recent Posts
    • To Meet or Not to Meet: Day 70 and Counting July 18, 2025
    • Blood Pressure Rising: FDA Warning Letter Takes an Aggressive Approach on General Wellness Product July 17, 2025
    • CMS Proposals Would Raise the Bar on Bona Fide Service Fees for Average Sales Price July 16, 2025
    • ACI’s Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition July 15, 2025
    • Federal Hiring Shake-Up (Again): What the Latest Executive Action and Supreme Court Decision Mean for Industry July 14, 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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    • Big Molecule Watch Blog
    • Bloomberg BNA Health Care Blog
    • Drug and Device Law Blog
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    • Internet Drug News.com
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