The New Drug Approval Process: Basic Concepts

Recognize the difference between a “drug” and a “new drug” under the Federal Food Drug and Cosmetic Act (FDCA). Learn the various approval pathways for bringing a new drug to the U.S. market. Understand the scientific standards by which FDA will approve a new drug.

Jason F. Conaty, Counsel, Global Regulatory, Hogan Lovells US LLP

This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in November 2023. 

Get Access

$149
  • +$100 for nonmembers

Internet Explorer and Microsoft Edge are not supported by the checkout process.

Please use Chrome, Firefox, or Safari.  If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.

Virtual Learning FAQ

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.

 

On-demand content can be played back on most devices.

 

CLE credit is not currently available for pre-recorded sessions.

Related Content