Pharmacies To Distribute MedWatch Number Under FDA Adverse Event Reporting Rule
This article was originally published in The Pink Sheet Daily
Executive Summary
The proposal incorporates Best Pharmaceuticals for Children Act provisions into the existing MedWatch program. The compliance costs for pharmacies already providing written consumer medication information is expected to be low.
You may also be interested in...
Adverse Event Hotline On Pill Bottles Would Be Required Under PDUFA Legislation
Draft bill states that FDA’s proposed rule would go into effect within 60 days of passage.
Adverse Event Hotline On Pill Bottles Would Be Required Under PDUFA Legislation
Draft bill states that FDA’s proposed rule would go into effect within 60 days of passage.
Serious Adverse Event Reports To FDA Increase in 2003
CDER “Report to the Nation” shows 68% increase in number of “serious” events captured in manufacturer periodic reports during 2003. The agency received a total of 370,997 adverse event reports in 2003, an increase of 15%.