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  • 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
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  • Regulatory Updates
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    • About PDG – An FDA Regulatory Consultant
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Daily Archives: June 16, 2016

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When to Change Prescription Drug Labeling

When to Change Drug Labeling?

Labeling / Marketing, Pharmaceutical Consulting News, Regulatory Affairs, Safety & PharmacovigilanceBy BRG Regulatory ExpertJune 16, 2016

You don’t have to be a drug labeling consultant to realize that a case series of serious events in the literature, FDA safety alert, FDA labeling change notification letter, or other new safety information should prompt a review of drug product labeling (aka package insert). That is not what this paper is about. This paper…

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    Pharmaceutical Development Group

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