Sat, Aug 31, 2013 - Page 3 News List

Drug firms using public as ‘guinea pigs’: activist

By Alison Hsiao  /  Staff reporter

“They are all post-approval changes. As post-approval changes can be, according to international standards, categorized into major and minor changes, it is only when major changes take place that a further risk assessment is needed,” Tzou said.

The FDA released a statement later in the day saying that a risk assessment meeting evaluating the drugs that underwent major changes — about 5 percent of the drugs where post-approval changes have been made — would be held within the next month.

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