Do you have questions about the use of investigational drugs for treatment purposes?
Expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.
On Tuesday, February 23, at 3 p.m. ET, the FDA hosted a 30-minute webinar on Access to Investigational Drugs. The featured speakers, Theresa Toigo, Director, Office of Special Health Issues and Richard Klein, HIV/AIDS Program Director, Office of Special Health Issues, discussed factors to consider in deciding whether to seek access to an investigational drug and the ways to access investigational drugs.
Title: Access to Investigational Drugs
Web address for viewing: https://webmeeting.nih.gov/p14874544/
- FDA Basics Webinar: "Mini-Sentinel," FDA's New Tool for Monitoring the Safety of FDA-Approved Medical Products
- FDA Webinar on Prescription Drug Shortages
- Where can I find information about adverse reactions to a medicine prescribed for my child?
- Where can I find information about medicines prescribed for my child?
- Materials from Webinar on Access to Investigational Drugs
- FDA Webinar on "Bad Ads" Program
- FDA Basics Webinar on Generic Drugs
- What are over-the-counter (OTC) drugs and how are they approved?
- How FDA Evaluates Regulated Products: Drugs
- What is counterfeit medicine?
- How can I stay better informed about drugs? Is there a reliable website FDA recommends?
- What is an FDA Drug Safety Communication?
- How do I discard medicine that I no longer need, do I just throw it in the garbage?
- What are unapproved drugs and why are they on the market?
- How do I report a bad reaction to medicine or medication error to FDA?
- Does FDA approve the proprietary names of prescription drugs?
- What does FDA require drug manufacturers to do to prevent contaminated drugs? If contamination occurs, how must they correct the problem?
- How does FDA help consumers when drug shortages happen?
- Can FDA ban direct-to-consumer drug advertising?
- How does FDA oversee domestic and foreign drug manufacturing?
- Why isn’t a drug taken off the market when a manufacturer gets a Warning Letter?
- What is a Warning Letter?
- How does FDA decide when a drug is not safe enough to stay on the market?
- Does FDA approve the information given out by pharmacies when I pick up my medicine?
- Why do some drug labels get changed so often ?