TRANSACTIONS INVOLVING FDA-REGULATED COMPANIES
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
Due Diligence Reviews
♦ 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
Contract Drafting -- Both comprehensive and addressing specific clauses:
♦ Product development and FDA-related milestones
♦ Indemnification – regulatory compliance
♦ Regulatory-related covenants, warranties & representations
For presentations and articles on Transactions involving FDA, click here ...
FDA Legal Services -- for the life of a Life Sciences company
Product/Issue Specific FDA Legal Services
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Links to Our Other Services
Life Cycle FDA Legal Services
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© 2012 Michael A. Swit. ALL RIGHTS RESERVED.
Questions?
Contact us @ 760-815-4762 or mswit@fdacounsel.com
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