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Latest From Sue Sutter
US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking and testing reference product attributes according to criticality.
Agency summaries contained in reviews of novel drugs and biologics are useful and informative but difficult to find, and their use should be expanded to other types of applications, industry sponsors and other external stakeholders say.
Opponents say including data from a small pediatric trial of Purdue's buprenorphine patch could give the impression the study was more robust than it actually was, while supporters say labeling should reflect any available data that can inform pediatric prescribing.
'Believe it or not, we don't have as many disease-specific guidances as you would suspect on the new drug side,' Commissioner Gottlieb says.
New office will develop agency-wide patient engagement policy and serve as entry point for patient groups new to FDA, but will not interfere with existing relationships between advocates and the drugs and biologics centers, FDA Commissioner Gottlieb says.
Advisory committees will discuss whether data from a 41-patient study should be added to Pediatric Use section of labeling for Purdue's buprenorphine product; agency's decision to convene expert panel even though a pediatric indication is not being considered grew out of criticism generated by approval of OxyContin for adolescents.