Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to “discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial.”
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Partial Rosiglitazone/RECORD Chronology
- Rosiglitazone goes on the RECORD, but is it a hit? (June 5, 2009)
- Senate releases Avandia report, GSK responds to attacks (February 20, 2010)
- More Avandia action: Nissen secretly recorded GSK execs, FDA announces safety review (February 22, 2010)
- Avandia again: Nissen and JAMA editors spin RECORD round and round (March 23, 2010)
- EHJ editors rebuffed GSK efforts to suppress Nissen editorial on rosiglitazone (April 30, 2010)
- Tightening the noose yet again on Avandia(June 28, 2010)
- NEJM editors were “not fully aware” of GSK and Merck manipulation of Avandia and Vytorin DSMBs (July 7, 2010)
- 5 different ways of spinning RECORD (July 9, 2010)
- NY Times: GSK concealed negative Avandia study (July 13, 2010)
- Live Blog of the 2 Day Panel (Part 1, Part 2, Part 3, Part 4) (July 13-14, 2010)
- Avandia aftermath: who are the winners and losers? (July 16, 2010)
- 2 Avandia panel members found to have received money from GSK and Takeda (July 20, 2010)
- FDA puts TIDE on “partial clinical hold” (July 21, 2010)
- BMJ papers increase pressure on Avandia (September 7, 2010)
- 2 FDA rebels criticize inclusion of Avandia defenders on July advisory panel (September 13, 2010)
- FDA keeps Avandia on market, re-adjudicates RECORD, halts TIDE; EMA suspends Avandia marketing (September 23, 2010)
- FDA Announces Details of Severe New Restrictions on Rosiglitazone (May 18, 2011)
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