...This time over Avandia
How many warnings are needed before action is taken?
VIA FEDERAL EXPRESS
Jean-Pierre Garnier, Ph.D.
Chief Executive Officer
GlaxoSmithKline
Five Moore Drive
Research Triangle Park, NC 27709
Dear Dr. Garnier:
On August 20 through November 13, 2007, an inspection was conducted at your corporate headquarters, located at Five Moore Drive in Research Triangle Park, NC, by the United States Food and Drug Administration (FDA). The inspection focused on your firm's compliance with Postmarketing Adverse Drug Experience (PADE) reporting requirements and other postmarketing reporting requirements relating to Avandia (rosiglitazone maleate), approved by FDA on May 25, 1999, under NDA 21-071.
Our inspection revealed that your firm failed to report data relating to clinical experience, along with other data and information, for Avandia, as required under Section 505(k)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355(k)(1)] and Title 21 of the Code of Federal Regulations (21 CFR) Sections 314.80 and 314.81. In particular, the inspection found that your firm failed to report multiple postmarketing studies involving Avandia in mandatory Periodic and/or NDA Annual Reports. Failure to comply with Section 505(k) of the Act is a prohibited act under Section 301(e) of the Act [21 U.S.C. § 331(e)].
The deviations observed during the inspection demonstrating your firm's failure to comply with 21 CFR §§ 314.80 and 314.81 include the following:
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