Hot Story – Yes or No – Should You Shut Down Production During an FDA Inspection?
March 18, 2013 – Updated March 20 Hot story of the week! Our recent Webinar speaker, Dennis Moore, AUK Technical Services, noted that while having your production system down during an inspection is not necessary, it can be useful in some situations. On the ‘no’ side, Moore noted that most 483 hits come on records […]
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Astrazeneca Cuts 1200 Jobs in Delaware
The drugmaker AstraZeneca said Monday that it would cut or move 1,200 jobs from its facility in Wilmington by the end of 2015, with the research and development functions mainly going to Gaithersburg, Md. The British-based pharmaceutical giant has struggled in recent years as profits from key drugs plummeted because of generic competition, and it […]
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Boehringer Hit for Ad Masking as Press Release
FDA Hands Out CAPA 483s Like Candy The drugmaker does not believe so, but the Swedish Medical Products Agency disagrees. And so, the regulator upheld a decision to prevent Boehringer Ingelheim from using a press release about its Pradaxa bloodthinner after ruling a 2011 missive was really an advertisement aimed at the general public, PM […]
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Fact or Fiction – $1 Billion to Develop a Drug?
FDA Hands Out CAPA 483s Like Candy After years of debate over the cost of developing a drug, GlaxoSmithkline ceo has uttered a sentence that might resolve the issue once and for all – or reignite the argument. Speaking at a healthcare conference in London last week, Andrew Witty explained that the $1 billion cost […]
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Affymax Death May Be Near
After recalling its only marketed drug after 19 cases of anaphylaxis, a serious and life-threatening allergic reaction that led to three patient deaths, Affymax is considering a sale, unwinding operations or bankruptcy. For now, 230 employees – or 75 percent of its workforce, including many commercial and medical affairs field personnel – are being laid […]
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5 Do’s and Don’ts for Your Next cGMP FDA Inspection
March 19, 2013 Hot Story – Avoid a CAPA File Inspection Disaster Our Webinar last week with Dennis Moore on cGMP FDA inspection tips, tricks, disasters and horror stories was really informative (and it’s rebooked for April 11). What I liked the most was his very simple point that FDA investigators are people too. If […]
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Choppy Road Ahead for Confusing eCopy Initiative
Avoid Problems with CDRH eCopy March 19, 2013 On Jan. 1, 2013, the new FDA guidance titled ‘eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff” went into effect. This guidance provides us with instructions on how to do medical device submissions to the agency with eCopy. If you […]
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Facebook Frisking Your FDA Auditor; Why You Should Shut Down Production During 483 Inspection
March 18, 2013 Â The $100,000 FDA Compliance Disaster FDA Auditors Use Facebook, Too Audit Tip #1 – Facebook Search! In our Webinar with Dennis Moore last week, he provided some extremely insightful and colorful commentary on things you should and shouldn’t do in your next FDA inspection. One I particularly liked was why […]
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Astrazeneca Chops 1,600 Jobs
Avoid Warning Letter Disasters With a Strong Quality Agreement In the latest effort to jumpstart its flagging business, AstraZeneca is consolidating R&D and global marketing operations over the next two years, a move that will eventually elminate 1,600 jobs by 2016, including 650 positions in the US. As part of the plan, the drugmaker is […]
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Mold – Another Compounding Pharmacy Recall
Avoid Warning Letter Disasters With a Strong Quality Agreement In the latest fallout from the compounding pharmacy scandal, a compounder has recalled all of its nearly 100 products after a Connecticut hospital noticed “visible particulate contaminants†that turned out to be mold in 50 millimeter bags of an intravenous solution. The move was disclosed on […]
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