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Latest From McKesson Corp.
iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data
Panel favors elimination of 19-day lockout after patients who can become pregnant miss the first prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.
iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.
REMS Vendor Disruptions Prompt Greater US FDA Scrutiny
McKesson’s exit from the space forced sponsors to switch vendors managing their REMS programs, which in some instances affected patient access to drugs. Omnibus legislation requires GAO report and collection of public input on factors FDA should consider in reviewing vendor changes.
McKesson Settles 2018 Price Fixing Suit With $141m Payment
US distribution giant McKesson has reached a nine-figure settlement deal with shareholders to resolve a class action lawsuit alleging that it participated in a price-fixing and anticompetitive scheme for generic drugs with manufacturers and other wholesalers.
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