FDA Regulatory Strategy and Freedom-to-Operate ("FTO") Validation (for Investments and Financings)
♦ Ensuring correct regulatory pathways
♦ Product line extensions
♦ Franchise protection (non-patent)
♦ Overcoming regulatory obstacles (e.g., Hatch-Waxman Exclusivity; approval criteria)
♦ FDA regulatory process impact on FTO
Due Diligence Review
♦ Assessing FDA-related strengths and weaknesses of targeted companies/products
♦ FDA compliance issues presented by target transactional parties
♦ FDA approval status assessments
Contract Drafting -- Comprehensive and Specific Clauses
♦ Product development and FDA-related milestones
♦ Indemnification – regulatory compliance
♦ Regulatory-related covenants, warranties & representations
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