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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
Xellia Pharmaceuticals and the FDA have agreed on a modified consent decree so Xellia can resume manufacturing at the Bedford, Ohio, site it purchased from Ben Venue Laboratories. Read More
Public Citizen is suing the FDA for withholding details about members of its advisory committees and panels, contending that this information could expose potentially problematic relationships with industry. Read More