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
FDA Regulatory Initiatives Impacting Marketed Products
♦ “Offensive” and "Defensive" Use of FDA
Regulatory
Process
• Petitions
• Comments on other actions
• Comment preparation
• Legislative responses
State Issues
• qualifying
• challenges to listings
• 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
Recalls
♦ Assessing need for recall
♦ Implementation
• Risk classification process
• Logistics
♦ Managing Products Liability Risks
|
