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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
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    • Specialty Services
      • Specialty Services
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      • Legal Support
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      • 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

Category Archives: Strategic Drug Development Services

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Drug Development Services

FDA Communications: Part II

Strategic Drug Development ServicesBy PDG Regulatory ExpertAugust 12, 2019

As a continuation of FDA Communications: Part I, this article will discuss the other two major types of communications with the FDA that were not discussed in Part I. As a reminder, there are four major types of communications with the FDA: Administrative meetings and communications Regulatory communications Product application meetings Public administrative proceedings This…

Choosing the Right Clinical Trial Design

Choosing the Right Clinical Trial Design

Strategic Drug Development ServicesBy PDG Regulatory ExpertJune 22, 2019

Drug developers have a daunting task when it comes to selecting the correct clinical trial design. Choosing the wrong clinical trial design can prolong the development time and create unnecessary expenses. It is important to explore the benefits for the different clinical trial design types, such as conventional clinical trial design and adaptive clinical trial…

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