Food and Drug Administration (FDA)

Summary:

Sigmatech provided Instructional Design, Course development and implementation for content provided by the FDA.  The courses were hosted both on Sigmatech Systems and on FDA’s LMS.

Services Provided:

  • Bad Ad Recognition and Reporting
  • Chemistry, Manufacturing and Controls
  • Human Drug Establishment and Drug Listing Compliance
  • Engaging with the FDA During New Drug Development
  • Generic Drug User Fee Act (GDUFA)
  • FDA State Tobacco Compliance Check Inspection Program
  • Best Practices for Communication Between FDA and IND Sponsors During Drug Development
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