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On January 25, 2018, the United Stated Department of Justice under Attorney General Jeff Sessions reversed decades of accepted regulatory agency practice by substantially reducing the importance and significance of Guidance Documents for not only life sciences companies, but all industry segments. Although ironically the policy position was itself not effectuated by statute or notice-and-comment rule making, the statement in effect, reduces regulated industry’s ability to rely on government guidance.

Although Guidance Documents are implemented unilaterally by agencies without administrative law requirements of notice-and-comment rule making, these documents are essential for companies in fast-paced innovative industry segments — especially life sciences. Without the ability to “rely” on Guidance Documents as the accepted “thinking” of FDA and other regulatory Agencies, companies will face increased uncertainty in the market authorization, promotional activities, and manufacturing regulatory contexts. Finally, Guidance Documents put bad-actor companies “on notice” of what to expect from regulators. These documents are essential for consumer protection in a rapidly-changing industrial landscape, as well as a landscape littered with companies and individuals that would lie, cheat and steal for financial gain, and put the American public at risk.

See my LinkedIn post below:

Filed Under: FDA Enforcement, Regulatory Alert

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      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
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      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
    • REMS
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

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