FDA Aims to Ease Access to Investigational Drugs

New rules make the drugs more widely available to seriously ill patients outside clinical trials
By Andrea Mongler
HealthDay Reporter

WEDNESDAY, Aug. 12 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) has published two new rules to help seriously ill patients gain access to investigational drugs and biologics, according to an Aug. 12 release issued by the agency.

Options for these patients include being treated with a drug that has been approved by the FDA, taking an investigational drug as part of a clinical trial, and taking an investigational drug outside of a clinical trial. One of the new rules clarifies procedures and standards to make investigational drugs more widely available to patients. The other rule clarifies which circumstances and costs related to an investigational drug a manufacturer can charge patients for, either as part of or outside of a clinical trial.

The FDA is also launching a Web site where patients and their health care professionals can learn about options for investigational drugs.

"With these initiatives, patients will have the information they need to help them decide whether to seek investigational products. For patients seeking expanded access to investigational drugs and biologics, the new rules make the process easier to understand," Margaret A. Hamburg, M.D., Commissioner of Food and Drugs at the FDA, said in a statement.

More Information
Access to Investigational Drugs

Copyright © 2009 ScoutNews, LLC. All rights reserved.

Powered by

Featured Jobs



Benefits of Membership

FREE E-Newsletters
Sign up for our free enewsletters to stay up-to-date in your area of practice - or take a look at an archive of prior issues

CESaver
Join our CESaver program to earn up to 100 contact hours for only $34.95
Register Now

Lippincott's NursingCenter.com
Explore a world of online resources

Become a Member