Investigational New Drug (IND Submissions
• preparation
• submissions
• initial filing
• maintenance during life of the IND – changes
• Clinical Trial Protocol Reviews
• Informed Consent Reviews
New Drug Applications (NDAs), Biologics Licensing
Applications (BLAs), and Abbreviated NDAs (ANDAs)
♦ Counseling on requirements
♦ PDUFA and Application Fees
♦ Strategies to maximize approval process
♦ Responding to FDA Complete Response &
Refuse-to-File letters
♦ Achieving binding agreements with FDA on
clinical design
FDA Liaison & Meetings
♦ End-of-Phase meetings (I, II, III)
♦ Advisory Committee preparation and meetings
Promotion and Advertising During R&D & Pending
Approval
Orphan Drug Designation & Development
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Brand-Generic Competition Issues
♦ Non-patent product line extension
• strategies to change innovator products
• 505(b)(2) applications – major changes to
approved products
♦ Legal challenges to generic entry
• the listed drug
• legitimate scientific issues on equivalence
• Hatch-Waxman market exclusivity eligibility
♦ Direct challenges to generic “equivalence”
♦ ANDA Suitability Petitions – easing the regulatory
burden
Emerging FDA Issues & Their Impact on Development Plans
♦ Comment preparation on FDA initiatives
♦ Legislative responses
♦ Client-generated strategic initiatives
Changes to Approved Products
♦ Regulatory Requirements counseling
• Supplements
• Annual Reports
Adverse Event Handling
♦ Regulatory classification of event
♦ Implementing
♦ Managing Related Products Liability Risks
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