Avastin Widespread Availability For Eye Use May Depend On FDA Clearance
FDA has taken center stage in the skirmish over Avastin's off-label use in patients with age-related macular degeneration
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Eye doctors furious over Genentech's decision to halt sales of Avastin to compounding pharmacies have succeeded in grabbing the company's attention. On Oct. 26, three of Genentech's top officers, CEO Arthur Levinson, Chief Medical Officer Hal Barron, and president of product development, Susan Desmond-Hellmann, traveled to Washington, D.C. to meet with two physician groups
Issues surrounding off-label dissemination may be clarified through regulations required by the FDA Amendments Act of 2007
The Centers for Medicare & Medicaid Services may serve as a stronger regulatory presence for pharmacy compounders in light of a recent federal court decision rejecting FDA's enforcement authority over the practice