« Return to News | Ethics/Regulatory

FDA Launching New Rules to Expand Access to Investigational Drugs

Thursday, August 27, 2009 09:16 AM

The U.S. Food and Drug Administration published two new rules to help seriously ill people gain access to investigational drugs when they are not eligible for clinical trials and have exhausted other treatment options.

The rules, which go into effect in mid-October, clarify the procedures, standards and costs of providing investigational drugs as part of a clinical trial or when used outside the scope of a trial.

The FDA also has dedicated a portion of its web site to providing patients and health care providers with information about investigational drugs that have been approved by the FDA or are being given as part of clinical trials.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.