Table of Contents
Entering the US Market for pharmaceutical and medical device products
- FDA Regulation on Therapeutic Products
- Regulatory challenges in entering the US market
- Preparation for regulatory support
2. COVID-19 and FDA policies during the pandemic
- Emergency Use Authorization - Overview
- EUA for medical devices and pharmaceuticals
- Changes in the FDA due to the pandemic
3. Supply chain for therapeutic products in the US
- Shortcomings in the US supply chain for therapeutic products revealed by COVID19
- Biden Administration's "America's Supply Chains" executive order and its impact in the healthcare/ biopharma industry
4. Summary and Implications
