Two key pieces of legislation, enacted to spur drugmakers into testing pharmaceutical products in children, are up for reauthorization in the US Congress this October. Have they done their jobs?
Advertisement
The Scientist
Most Recent
The Pediatric Research Equity Act (PREA) of 2003 requires that companies developing new drugs that could be used to treat a condition in children perform clinical trials in kids before winning FDA approval. The Best Pharmaceuticals for Children Act (
Studies on safety, efficacy, or dosing of drugs in children, or on nutritional supplements, are not run-of-the-mill.
The federal agency finally breaks out some information on what it might take to get generic biological drugs approved.
Current and former employees of the US Food and Drug Administration have filed suit, alleging that their employer spied on them for whistleblowing.
Legislation proposes speeding certain drug applications submitted to the US Food and Drug Administration.
After a lightning-fast approval, the first medicine to treat an underlying cause of the disorder hits the market.
Breast implants leaking contaminated silicone are causing a fuss in Europe, but all breast implants carry risks.
The FDA approved 30 drugs last year, the highest number in the last 7 years.
The agency has limited the use of antibiotics in farm animals.
Follow The Scientist
Stay Connected with The Scientist
-
The Scientist Magazine
-
The Scientist Careers
-
Neuroscience Research Techniques
-
Genetic Research Techniques
-
Cell Culture Techniques
-
Microbiology and Immunology
-
Cancer Research and Technology
Current Issue
