Expanded Access and Right-to-Try

The following are links to more information about the drug approval process, expanded access, compassionate use, right-to-try, etc.

FDA Drug Approval Process: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/

• Clinical Trials (FDA): https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm
• Clinical Trials (NIH): https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
• Clinical Trials (clinicaltrials.gov): https://clinicaltrials.gov/ct2/about-studies/learn
• Clinical Trial Phases (blog post): https://www.als.net/news/the-clinical-trial-process-the-four-phases-explained/

Webinar: https://www.neals.org/for-people-with-als-caregivers/educational-webinars/right-to-try-historical-legal-and-ethical-considerations

FDA Expanded Access (aka, Compassionate Use): https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm

Right to Try:

• FDA: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try
• Advocacy group: http://righttotry.org/faq/
• Article discussing pros and cons of right-to-try: https://alsnewstoday.com/2018/02/12/rare-disease-groups-patients-differ-on-right-to-try-bill-before-us-congress/