KHIDI Brief - US Regulatory Landscape for Therapeutic Products


Table of Contents


  1. 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



US Regulatory Landscape for Therapeutic Products_Final
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