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  • Home
  • Services
    • Pharmaceutical Consulting Services
    • Strategic Drug Development
      • Strategic Drug Development Services
      • Pharmaceutical Development Programs: Implementation and Oversight
      • Pre-IND Meetings
      • Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)
      • Clinical Trial Design
      • Pre-NDA Meetings and NDA Submissions: 505(b)(1)/505(b)(2)
      • 505(b)(2) NDAs
      • Generic Drugs: 505(j) ANDAs and Potential Diversification
      • Nonprescription Drugs (OTC)
    • Medical Device Consulting
      • Exempt Devices / 513(g) Submissions
      • Device Pre-submission Meetings and Reviews
      • Facility Inspection Readiness
      • Combination Device and Drug/Biologic Submissions
      • 510(k) Submissions
      • PMA Submissions
    • Post-Launch Activities
      • Drug Post-Launch Activities
      • Post-Marketing Surveillance
      • Drug Labeling
    • Specialty Services
      • Specialty Services
      • Citizen Petitions
      • Legal Support
      • Literature Searches
      • Pharmacokinetic Consulting
      • Quality Assurance & Compliance
      • Scientific and Technical Writing
      • Supplier/Vendor Selection and Qualification
      • Toxicology Consulting
  • Regulatory Updates
  • About PDG
    • About PDG – An FDA Regulatory Consultant
    • Your Pharmaceutical Consultant
    • Careers at PDG
  • Regulatory Resources
    • Regulatory Resources
    • FDA Links
    • International Health Authority’s Websites
  • Contact PDG

Daily Archives: January 31, 2017

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January 25, 2017: New ANDA Guidance; New Reference Standard Data Added to Orange Book

Breaking NewsBy PDG Regulatory ExpertJanuary 31, 2017

On January 25, 2017, FDA introduced an important new data update to the Orange Book . Search results and drug listings will now “clarify which listed drugs are reference listed drugs (RLDs) and which are reference standards. Listings also indicate which products in the Discontinued Section may be referred to as an RLD. The FDA…

January 23, 2017 – FDA Cuts Federal Register Wait for Certain ANDA Approvals

Breaking NewsBy PDG Regulatory ExpertJanuary 31, 2017

According to FDAnews Drug Daily Bulletin “FDA said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness. Previously, the FDA would publish its findings that a drug was removed from the market for reasons other than its…

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