Raising Capital in a Highly Regulated Market
Healthcare Law Insights blog
MARCH 12, 2025
Investors want clarity on whether a company is pursuing a 510(k), De Novo, PMA, or Breakthrough Device Designation for medical devices, or an IND/NDA/BLA pathway for pharmaceuticals. Regulatory ambiguity is a dealbreaker. Uncertainty in how a product will be regulated adds risk and can stall investment. Regulatory engagement adds credibility.
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