DEA Leaning on FDA to Strictly Regulate Opioid Painkillers
April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission The Drug Enforcement Agency (DEA) is recommending stricter labels on oxycodone and hydrocodone painkillers to help curb abuse of the drugs. In a letter sent to the Food and Drug Administration (FDA) last week, the DEA endorsed a citizen […]
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Is GSK Pressure on FDA Influencing Hospira 483 Failures?
5 Do’s and Don’ts for Your Next FDA Inspection Yes or No – Should You Shut Down Production During Your FDA Inspection? March 26, 2013 In recent months, we have seen major manufacturing issues with the Hospira facility in Rocky Mount, NC. Hospira is reported to have spent upwards of a staggering $375 million since […]
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Another J&J Recall Disaster
Is GSK Pressure on FDA Influencing Hospira 483 Failures? And yet another product recall from Johnson & Johnson. The latest involves 1.9 million OneTouch Verio line of blood glucose meters, which were malfunctioning at extremely high blood glucose levels. Three different models either failed to display the proper warning and turned off or displayed incorrect […]
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Hospira 483 Shows Killer Manufacturing Issues
April 21 – $500K on Compliance or $300 Million for Consent Decree? – Essential FDA Compliance Tips for Sr Management When Hospira ($HSP) acknowledged this month that FDA inspectors were still dissatisfied with progress at its Rocky Mount, NC, plant, it left out any details about what led them to their conclusions. The FDA has […]
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FDA To Track Illicit Product Trade Online
April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance FDA plans to monitor the Internet to ensure that prescription drugs, tobacco and other regulated products aren’t illicitly traded or marketed online. In procurement documents posted online March 21, the FDA plans to hire a contractor to look for […]
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Upcoming Expertbriefings.com Webinars 2013
Upcoming Expertbriefings.com Webinars 2013 Check out our latest FDA drug and device news, too . April 11 – The Quality Manager Gets Fired, the $100,000 Compliance SNAFU, And 21 Tips and Tricks For Your Next Audit April 18 – Why You May Want to Move Your Pharma Company to Kansas – 483 and Warning Letter […]
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Unusual Exit – Clinical Trial Subject Jumps From Window
This may be the odd story of the month. Back on March 4, a 32-year-old man claimed that represenstatives of an unnamed drugmaker based in Miyapur, India, tried to force him to participate in a clinical trial in which he had enrolled. He had volunteered, but changed his mind after he arrived because he had […]
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Bankrupt CEO Offers FB Gift Coupons for Clinical Trial Subjects
Last year, PRACS Institute emerged from the ashes of Cetero Research, a troubled contract research organization that filed for bankruptcy after the FDA alerted drugmakers to reevaluate clinical tests conducted due to falsified data and manipulated samples (back story). Now, though, PRACS has folded and late last week filed for bankruptcy, leaving drugmakers and clinical […]
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FDA Dumps Grotesque Cigarette Warnings
Upcoming Expertbriefings.com Webinars April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 16 – The Quality Manager Gets Fired, the $100,000 Compliance SNAFU, and 21 Tips and Tricks for Your Next […]
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FDA Issues Warning on GA Compounding Pharmacy Recall
May 7 – FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy FDA is warning doctors that a Georgia-based compounding pharmacy is recalling dozens of lots of the Roche drug Avastin after receiving reports of eye infections among patients. The FDA said last week that Clinical Specialties of Martinez, Ga., has […]
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