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1
Regulatory Guidelines And
Laws Governing Pharmacovigilance
1/10/201
7
Katalyst Healthcares & Life Sciences
FDA EMEA MHRA
MHLW
and
PMDA
CDSCO
Who regulates Drug Safety:
 Assess safety warnings
 Labeling change
 Withdrawal
Regul...
The US FDA is a scientific, regulatory, and public health agency.
MedWatch is the FDA’s reporting system for adverse event...
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