Avastin Point/Counterpoint: Hamburg Responds To Genentech’s Arguments On Breast Cancer Claim
Executive Summary
In a point-by-point response, FDA Commissioner Hamburg rebuts Genentech’s many and varied arguments for maintaining bevacizumab’s accelerated approval in first-line metastatic breast cancer.
You may also be interested in...
Avastin Decision Leaves Lingering Uncertainty As To Threshold Level Of Progression-Free Survival Benefit
In her memo revoking Avastin’s metastatic breast cancer claim, FDA Commissioner Hamburg declines to adopt a “bright-line” cutoff of median PFS improvement that would be necessary to establish efficacy, despite industry’s desire for more certainty about the threshold for approval.
Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works
FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.
ADHD Drugs: FDA Commissioner Blames Inappropriate Prescribing For Shortages
ADHD drug shortages may have resulted from industry reticence to fill DEA quotas, as well as a 'heavy element of professional responsibility' with off-label prescribing, Robert Califf told a House appropriations subcommittee.