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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
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      • Pharmacokinetic Consulting
      • Quality Assurance & Compliance
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      • Supplier/Vendor Selection and Qualification
      • Toxicology Consulting
  • Regulatory Updates
  • About PDG
    • About PDG – An FDA Regulatory Consultant
    • Your Pharmaceutical Consultant
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  • Regulatory Resources
    • Regulatory Resources
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  • Contact PDG

Daily Archives: September 2, 2016

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FDA Requires Boxed Warnings to Address Combination Use of Opioids/Benzodiazepines

Breaking NewsBy PDG Regulatory ExpertSeptember 2, 2016

In making its announcement FDA Commissioner Robert Califf, M.D. stated that “It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together…We implore health care professionals to heed these new warnings and more carefully and thoroughly…

RAPS Reports Reduction in Certain GDUFA User Fees for 2017

Breaking NewsBy PDG Regulatory ExpertSeptember 2, 2016

The revised user fees will go into effect October 1, 2016 and remain in effect through the end of September 2017.  It is important to note that not all fees will be reduced, and some will increase.  Following is an excerpt of the story, recently published in Regulatory Focus describing key changes: ANDA ($70,480, down…

FDA Issues New Draft Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device

Breaking NewsBy PDG Regulatory ExpertSeptember 2, 2016

Issued on August 8, 2016, regulatory impact includes the following: FDA issued the original Deciding When to Submit a 510(k) for a Change to an Existing 53 Device (K97-1) on January 10, 1997 to provide guidance on this regulatory language This draft guidance preserves the basic format and content of the original, with updates to…

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