FDA: Pfizer Concealed Serious Harm from Drugs - CBS News
(AP) Federal regulators have warned Pfizer for failing to promptly report complaints with its drugs that may have involved serious injury.
Pfizer repeatedly failed to submit product complaints to the Food and Drug Administration within the required 15 days, according to an FDA warning letter obtained by The Associated Press.
In some cases, Pfizer failed to report problems all together, including reports of serious side effects with the cholesterol drug Lipitor and the antiseizure drug Lyrica.
The New York-based company said in a statement it would work with the FDA to address the issues cited in the 12-page letter.
The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing, marketing and testing.
1 comment:
We've seen this before with Pfizer.
Check out the FDA's reviews of Saphis.
Pfizer VP Larry Alphs is noted in FDA documents as being involved in not reporting deaths to the IND. Failure to report SAEs to the IND is a misdemeanor in the US.
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