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The FDA’s Office of Generic Drugs is going to focus on meeting its scientific priorities from previous years, instead of setting out to accomplish new projects for this fiscal year – the final year of the five-year authorization for GDUFA. Read More
The Environmental Protection Agency has fined Pfizer almost $200,000 for storing ammonia and methylamine in amounts that exceeded regulatory thresholds. Read More
Boehringer Ingelheim posted positive trial results for another Humira biosimilar, just a month after the FDA approved Amgen’s version, Amjevita. Read More