Publications (2)106.6 Total impact
-
Article: Developing the nation's biosimilars program.
New England Journal of Medicine 08/2011; 365(5):385-8. · 53.30 Impact Factor -
Article: New FDA regulation to improve safety reporting in clinical trials.
[show abstract] [hide abstract]
ABSTRACT: As part of an initiative designed to modernize the clinical trial enterprise, the Food and Drug Administration (FDA) recently published a regulation establishing a new safety-reporting paradigm for drugs being studied under investigational new drug applications (INDs).(1) This rule - published last September and effective as of March 28, 2011 - is one in a series of steps the FDA is taking to enhance the protection of human subjects and improve trial conduct by streamlining the regulatory procedures for clinical trials. Monitoring patient safety during clinical trials is a critical component of the drug-development process. Such monitoring is a dynamic . . .New England Journal of Medicine 06/2011; 365(1):3-5. · 53.30 Impact Factor
Top co-authors
Top Journals
Institutions
-
2011
-
U.S. Food and Drug Administration
Washington, D. C., DC, USA
-
