FDA Legal Services Involving Marketed Products

FDACounsel.com -- Legal Services -- for the life of a Life Sciences company

MARKETED PRODUCT SERVICES

Advertising and Promotion
  ♦ Training
  ♦ SOP drafting and review
  ♦ Pre-release reviews
        • press releases
        • web sites
        • print and TV ads and scripts
Changes to Approved Products
  ♦ Regulatory Requirements counseling
        • Supplements
        • Annual Reports
  ♦ Implementation Tactics
FDA Regulatory Initiatives Impacting Marketed Products
  ♦ “Offensive” and "Defensive" Use of FDA Regulatory Process
        • Petitions
        • Comments on other actions
  ♦ Strategic responses
        • Comment preparation
        • Legislative responses
State Issues
  ♦ Drug Formulary
        • qualifying
        • challenges to listings
  ♦ Licensing Issues
        • manufacturing
        • pharmacy practice
  ♦ Compounding pharmacy regulation

Brand-Generic Competition Issues
   ♦ Non-patent product line extension
       • strategies to change innovator products
       • 505(b)(2) applications – major changes to
              approved products
   ♦ Legal “Blocking” of generic entry
       • altering the listed drug
       • legitimate scientific issues on equivalence
       • Hatch-Waxman market exclusivity eligibility
   ♦ Direct challenges to generic “equivalence”
Adverse Event Handling
   ♦ Regulatory classification of event
   ♦ Implementing
       • SOPs
       • Filings
Recalls
   ♦ Assessing need for recall
   ♦ Implementation
       • Risk classification process
       • Logistics
   ♦ Managing Products Liability Risks

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To see presentations and articles on FDA issues involving
Marketed Products, just click here ...