Jump to content
  • We are now offering Remote Courses

    Equal benefits to our residential courses, without the travel.

    View Courses
  • eLearning Passport

    All our courses. 12 months access. One flat fee.

    More Information
  • Newsletter

    Non-members can signup to keep up to date with RQA news and events.

    Add your details now

FDA - Draft Guidance on Charging for Investigational Drugs Under an IND

31st August 2022

FDA

Charging for Investigational Drugs Under an IND Questions and Answers - Guidance for Industry
DRAFT GUIDANCE.

This guidance provides information for industry, researchers, physicians, institutional review 18 boards (IRBs), and patients about the implementation of FDA’s regulations on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect on October 13, 2009.

Read Guidance

Back to Recent News

Share

Virtual Event Platform