TY  - JOUR
T1  - New drug: Caution indicated: comment on “new drugs and safety”
AU  - Moore TJ
Y1  - 2012/11/26
N1  - 10.1001/2013.jamainternmed.610
JO  - Archives of Internal Medicine
SP  - 1681
EP  - 1682
VL  - 172
IS  - 21
N2  - 
In assessing a new therapeutic drug, regulators at Health Canada and the US Food and Drug Administration (FDA) are entrusted with making critical and difficult scientific judgments that can affect the health of hundreds of thousands of patients in a matter of months after product launch. In drug evaluation, the cost of error may be high. Casualties in pharmaceutical disasters are measured in tens of thousands, and the population exposed to unsafe drugs often numbers in the millions.1 In a new research letter, Lexchin2 provides a valuable but basic report card for the drug approval decisions at Health Canada over a 16-year period.

SN  - 0003-9926
M3  - doi: 10.1001/2013.jamainternmed.610
UR  - http://dx.doi.org/10.1001/2013.jamainternmed.610
ER  -