MARKETED PRODUCTS
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
Product
s
    ♦ “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
To see presentations and articles on FDA issues involving
Marketed Products
, just click here ...
FDA Legal Services --  for the life of a Life Sciences company
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© 2014   Michael A. Swit.  
ALL RIGHTS RESERVED.

Questions?

Contact me @ 760-815-4762
or
mswit@fdacounsel.com
Michael A. Swit