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The FDA released updated GDUFA program fees for the 2018 fiscal year that come with a big hike in ANDA fees and include, for the first time, annual fees for ongoing marketing of approved generics. Read More
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