Kybella Approval Shows How To Work With FDA On Clinical Outcome Assessments
Kythera met FDA's strict evidentiary requirements for clinician- and patient-reported outcomes assessments through close and frequent interactions with the agency and by addressing regulatory concerns about the instruments' design, validation and use in Phase III trials for the submental fat treatment.
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Allergan Adds Accretive Aesthetics Assets In $2.9bn LifeCell Acquisition
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Behind The Approval Letter: Drug Review Profiles
A listing of the Drug Review Profile series articles published in the Pink Sheet.
Chin Fat Not A 'Serious Condition' Worthy Of Priority Review, FDA Says
Deoxycholic acid offers safe and effective alternative to 'unapproved and unregulated' pharmacy compounded products, Kythera asserted in unsuccessful bid for shorter review.