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Two FDA advisory committees recommended the FDA approve KemPharm’s opioid pill Apadaz, even though they rejected an abuse-deterrent label for the candidate. Read More
Two FDA advisory committees voted unanimously to recommend modifications to the REMS for extended-release and long-acting opioids, although the recommendation did not get into specific courses of action. Read More
The FDA is looking to shed light on the sometimes murky rules governing compounding operations to distinguish heavily regulated outsourcing facilities from tiny compounding operations that are lightly regulated. Read More
Janssen has moved to a continuous manufacturing process at one of its facilities after getting the green light April 8 from the FDA to switch from batch production, making it the first drugmaker allowed to change its production method mid-cycle. Read More
As the FDA ramps up its preparations for renewing PDUFA, industry and related groups are pushing for a greater focus on patient perspectives in its next iteration. Read More
Drugmakers and trade groups overwhelmingly want lower user fees and a clearer review process for GDUFA as the FDA looks to renew the user fees before the Sept. 30, 2017 cut-off date. Read More