Safety surveillance in drug development: understanding the process and its implications for nephrology nursing.
The more frequent introduction of new drugs and devices to the marketplace, including an increase in the number of trials, requires nephrology nurses to better understand the process and the implications for their practice. This article explains the pre- and post-marketing phases of drug development and describes the post-marketing safety surveillance of all FDA-approved drugs.
Browar
Susan
S
Luitpold Pharmaceuticals, Inc., Shirley, NY, USA.
D016907:Adverse Drug Reaction Reporting Systems; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000458:organization & administration*; D006801:Humans; D009398:Nephrology; D011358:Product Surveillance, Postmarketing; D013041:Specialties, Nursing; D014481:United States; D014486:United States Food and Drug Administration