The Hybrid Entrepreneur

APPENDIX

The Food and Drug Administration

Is your product pure, safe, and efficacious? The three conditions needed to get a drug approved by the FDA.

Introduction

Products that require FDA approval need greater attention in managing timelines, milestones, and barriers that might affect getting the products to market. The FDA requirements for early-stage life science products (therapeutic, diagnostic, medical device, and natural products) scare some investors but not the Boston investors. The role of the FDA is to protect the consumers with safe, pure, and efficacious products (www.fda.gov).

Medical Products

Nonhealth care investors are weary of the FDA because of the effect of milestones and timelines for getting the product to market. However, ...