Manipulated Records and Cover Ups Delay FDA Approval for Bristol-Myers Drug

Source: PharmaManufacturing.com

Jul 11, 2013

Bloomberg

The pharmaceutical industry needs high-quality trials, but can they get them in low-cost areas?

According to documents posted the U.S. Food and Drug Administration, Bristol-Myers Squibb and Pfizer’s blood thinner, Eliquis, was stalled for nine months because of misconduct, errors and an alleged cover-up attempt at a Chinese trial site. FDA documents show that patients got the wrong medicine, records were secretly changed and “serious adverse events” went unreported. Read more

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