Pharmalot’s Ed Silverman reports that a number of generic drugs, sold by Novartis and Teva Pharmaceuticals, may be pulled off of the shelves after it was revealed that they were approved based on “flawed studies.” The flawed studies all came out of an Indian clinical research organization, Semler Research Center, that was found to have “significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.”
“The findings from (the) FDA and WHO inspections call into question the quality management system in place at Semler…”
Hahaha. FDA and WHO slamming…anyone? Stating the obvious here: Pot calling kettle black. Clearly politically motivated, otherwise it’s just a joke.