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TRANSACTIONS INVOLVING FDA-REGULATED COMPANIES
OR PRODUCTS
OR PRODUCTS
- ♦ Product line extensions
♦ Franchise protection (non-patent)
♦ Overcoming regulatory obstacles (e.g., Hatch-Waxman Exclusivity;
generic biologics)
♦ FDA regulatory process impact on FTO
- ♦ Assessing FDA-related strengths and weaknesses of targeted
companies/products
♦ Defending FDA status of targeted firm/product
♦ FDA compliance issues presented by target transactional parties
♦ FDA approval status assessments
- ♦ Product development and FDA-related milestones
♦ Indemnification – regulatory compliance
♦ Regulatory-related covenants, warranties & representations
For presentations and articles on Transactions involving FDA, click here ...
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