« 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

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.