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IntelGenx Technologies must provide the US Food and Drug Administration with additional pharmaceutical quality information for an abbreviated new drug application referencing Collegium’s Belbuca (bup

The US Food and Drug Administration has issued far fewer complete response letters in 2020 than in the past several years, but a recent burst of actions could suggest a change is coming. Of the 11 CRL

Industry channeled its inner Scott Gottlieb during the outgoing commissioner's final week as head of the agency by unleashing a barrage of drug development announcements. Here's your news in brief: P

The US FDA’s Center for Drug Evaluation and Research is coming off what in many lights could be the best year ever for new drugs – a record number of novel agents, reviewed in record low times, reflec