FDA and the Surrogate Endpoint Controversy
Updated Daily – Read our latest FDA, cGMP Compliance News In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective […]
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UK Charges GSK With Market Abuse
Updated Daily – Read our latest FDA, cGMP Compliance News In the latest instance in which drugmakers have been accused of reaching　’pay to delay’ deals that harm consumers, the UK Office of Fair Trading late last week charged that GlaxoSmithKline colluded with three generic drugmakers to forestall the introduction of low-cost versions of its Seroxat […]
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Ex-Aptuit Employee Busted for Clinical Trial Data Scam
Updated Daily – Read our latest FDA, cGMP Compliance News Late last week, a former employee of the Aptuit clinical research organization was sentenced to three months in jail for altering pre-clinical trial data that was used to support applications to perform clinical trials, according to the UK’s Medicines and Healthcare products Regulatory Agency. The MHRA […]
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FDA Opts for Public Safety Over Pain Med Access
Updated Daily – Read our latest FDA, cGMP Compliance News FDA decided it seems to come down on the side of cutting down the abuse of opoids, rather than encourage more availability of these low cost painkillers. FDA is decided to not allow generic versions of OxyContin, according to a CDER decision this week. This […]
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Contract Manufacturing Organization Hit With cGMP Warning Letter
Updated Daily – Read our latest FDA, cGMP Compliance News A Canadian branch of the largest CMO in India was hit with a GMP warning letter this month because it did not investigate failed product batches or implement CAPAs. Jubilant HollisterStier, which is a subsidiary of Jubilant Life Sciences based in India, failed to follow […]
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Revision of Clinical Trial Ethics in Helsinki Declaration
Updated Daily – Read our latest FDA, cGMP Compliance News There has been a strong effort in recent weeks to update the ethical practices for many types of clinical trials. The World Medical Association is now revising several principles that are written in the Helsinki Declaration. Some of the revisions include improving protections for the […]
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Merck Opens New Manufacturing Facility in China
Updated Daily – Read our latest FDA, cGMP Compliance News Merck, known as MSD outside of the United States and Canada, opened a facility in Hangzhou, China to package Merck medicines for China and the Asia Pacific region, announced the company in an April 16, 2013 press release. The facility, a nearly $120-million investment by […]
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Big Shakeup Underway With Hospira Management
Updated Daily – Read our latest FDA, cGMP Compliance News For more than a year, Hospira has made headlines thanks to a spate of ongoing, serious and systemic manufacturing problems that have led to numerous FDA inspections and warning letters. The situation has grown so worrisome that some speculate a consent decree is likely (read […]
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House Committee Rips FDA on Troubled Drug Compounders
More Exclusive FDA cGMP Compliance News After months of anticipation, a House committee is holding a hearing today to review a scathing report about the extent to which the FDA knew about the manufacturing issues at the New England Compounding Center, which was tied to a nationwide outbreak of fungal meningitis, and a related compounding pharmacy called […]
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Why Didn’t FDA Bar Generic OxyContin?
More Exclusive FDA cGMP Compliance News In a highly controversial move, the FDA last night announced it would not approve generic versions of the older form of the OxyContin painkiller over concerns that the drugs would be susceptible to abuse. The decision hands a significant victory to Purdue Pharma, because the patent on the older […]
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