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There is no compelling reason, according to the petition, why the FDA should not approve generic competitors’ ANDAs as long as they meet accepted quality standards. Read More
The FDA cited multiple problems with labeling claims at a Phoenix manufacturer that specializes in colostrum, the milk produced by maternal mammals immediately after giving birth. Read More
The FDA cited a Montreal drugmaker for refusing to allow an FDA inspector to take photographs during an inspection — and said that alone can lead to a finding that products are adulterated. Read More
A United States appeals court revived an antitrust lawsuit against four drugmakers alleging that they hamstrung generics for Lipitor and Effexor XR. Read More