Harsh FDA Social Media Enforcement – Not Really, Report Finds
Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 3, 2013 A new report by the Eye on FDA blog has published an interesting report that attempts to assess the regulatory actions of FDA’s Office of Prescription Drug Promotion that were due to the increased usage of digital and social […]
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Social Media Not Attacked By FDA As Much as Thought
For the past few years, one obsession in the pharmaceutical industry is the proliferation of social media tools and the lack of regulatory guidance from the FDA on how to use them without getting into trouble (a back story here). The uncertainty, however, has not prevented drugmakers from tiptoeing into this marketing realm, but the […]
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Bizarre – Cancer Research Compound Robbery
Avoid FDA – Move to Kansas! April 2, 2013 There is a report out there about a Wisconsin researcher who is being charged with economic espionage. Specifically, he is being charged in the realm of investigational oncology. The researcher is named Huajun Zhao and is facing one count of economic espionage, which can get him […]
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4 Tips for Pharma in Social Media from Former FDA Commissioner
April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 2, 2013 Questions remain regarding social media use in pharma According to Peter Pitts, a former associate commissioner at FDA, there are a number of things that the pharmaceutical industry needs to learn in using social media. We […]
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FDA enforcement against Hospira likely: analyst
Hospira Inc. has “systemic†manufacturing and quality-control issues that will likely force the Lake Forest-based injectable-drug maker to accept a consent decree from federal regulators, according to a new report by analysts. The company, with 2012 net sales of nearly $4.1 billion, disclosed on March 5 that the U.S. Food and Drug Administration issued a […]
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UPS Hands Over $40 Million for Helping Internet Pharmacies Ship Illicit Meds
In the latest effort to crack down on the Internet pharmacy trade, United Parcel Service late last week agreed to forfeit $40 million in payments that were received from illicit online pharmacies and to adhere to a compliance program designed to ensure that such pharmacies will not be able to use its storied services to […]
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Pharma Facebook Advice – What FDA Expects
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 What a former associate commissioner at FDA – Peter Pitts – thinks pharma should be doing in social media from FDA’s perspective. Remember […]
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More Clarity Needed on FDA eSource Trial Data Draft Guidance
April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance April 1, 2013 There are numerous calls among clinical trial stakeholders for more clarity on FDA draft guidance that tries to reduce pitfalls in switching to electronic source data for future clinical investigations. Hospira Consent Decree Coming? The draft […]
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Hospira Consent Decree Coming?
Quality Agreement Tip – Definitions! April 1, 2013 It seems that Hospira cannot catch a break these days. The drug company has had to issue yet ANOTHER recall, the fourth this year, as it is still struggling to meet FDA requirements at its vital sterile injectables plant in Rocky Mount NC. Last week, Hospira […]
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Brass Particles – Another Hospira Manufacturing Mess?
Like The Gang That Couldn’t Shoot Straight, Hospira is encountering yet another manufacturing woe. Late last week, the drugmaker recalled a lot of sodium injectables after a customer identified several small grey-brown particles in a primary container. Although Hospira has not received any reports of adverse events or quality issues with samples associated with this lot, the move comes after […]
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