FDA to overhaul of safety data collection

Sharon Hope · medicine forum Guru Joined: 30 Apr 2005 Posts: 752

Finally!!!

FDA to overhaul of safety data collection

http://news.yahoo.com/s/ap/20060621/ap_on_he_me/drug_safety;_ylt=Ao_FgVl3tYiNLsFkgT4supes0NUE;_ylu=X3oDMTA3czJjNGZoBHNlYwM3NTE-

FDA to overhaul of safety data collection

excerpt:
The FDA requires manufacturers to report adverse events, including potential
safety issues, associated with use of their products. Those reports now flow
into the agency in both electronic and paper formats. Once received, they're
sorted and rerouted by hand. The new, Web-based system would accept the
reports electronically, then automatically add some preliminary analysis and
context before rerouting them to the appropriate center for attention,
Gottlieb said.

On the Net:

Food and Drug Administration adverse event reporting system:
http://www.fda.gov/cder/aers/default.htm

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