Services -- Marketed Products

Advertising & Promotion

   ♦  Training
   ♦  SOP drafting and review
   ♦  Pre-release reviews
      • press releases
      • web sites
      • print and TV ads and scripts 


                     For more details on Advertising & Promotion Services, click here.


Regulatory Initiatives Impacting Marketed Products

   ♦  “Offensive” and "Defensive" Use of FDA Regulatory Process
       • Petitions
       • Comments on FDA and competitor actions impacting the regulatory process


Brand-Generic Competition Issues

   ♦  Non-patent product line extension
       • strategies to change innovator products
       • 505(b)(2) applications – major changes to approved products
   ♦  “Blocking”  generic entry
       • altering the listed drug
       • legitimate scientific issues on equivalence
       • Hatch-Waxman market exclusivity eligibility
   ♦  Direct challenges to generic “equivalence” 


Safety Issues -- Recalls & Adverse Events

  Recalls 

   ♦  Assessing need for recall 

   ♦  Implementation 

      • Risk classification process 

      • Logistics 

   ♦  Regulatory classification of event
   ♦  Managing Products Liability Risks 


  Adverse Event Handling
   ♦  Regulatory classification of event
   ♦  Implementing
      • SOPs
      • Filings 


Changes to Approved Products

   ♦  Regulatory Requirements counseling
      • Supplements
      • Annual Reports
   ♦  Implementation Tactics 


State Issues

   ♦  Drug Formulary
      • qualifying
      • challenges to listings
   ♦  Licensing Issues
      • manufacturing
      • pharmacy practice
   ♦  Compounding pharmacy regulation 

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