DRUG STUDIES: WHY THE DELAY?

MARCH 01, 2007

Drugmakers are not keeping their promises. They have yet to start more than 2 of every 3 pending studies they said they would conduct after their products received FDA approval.

According to data posted on the agency's Web site, 899 of 1259 postapproval studies had not started as of September 30, 2006. The figures do not reflect completed studies.

To receive FDA approval, drugmakers oftentimes agree to perform additional studies of safety, dosing, and other issues after medications enter the marketplace. The studies are usually voluntary, and the agency cannot enforce fines for failing to conduct them.

Consumer groups and some lawmakers are urging legislation to give the FDA more authority over the studies.

The newly released FDA statistics indicated that 184 studies were on or ahead of schedule, and 144 had been submitted for agency review or terminated. Some of the studies—about 31—were labeled "delayed."




SHARE THIS SHARE THIS
0

Conference Coverage from ASHP Summer 2017 

Four years after they first launched the Summer Meetings in Minneapolis, Minn., the ASHP 2017 Summer Meetings and Exhibition was in Minneapolis once again.  

 

Pharmacy Times Strategic Alliance
 

Pharmacist Education
Clinical features with downloadable PDFs


Next-Generation Pharmacist® Awards


3rd Annual Convenient Healthcare and Pharmacy Collaborative Conference


SIGN UP FOR THE PHARMACY TIMES NEWSLETTER
Personalize the information you receive by selecting targeted content and special offers.