Bugs and More Bugs – An FDA cGMP Inspection Disaster
April 3, 2013 We came across a recent warning letter issued by FDA to an API supplier in Japan called Asada Milling. We would like you to take note if you have any drug products in your home that contains anything handled by this firm. Why, you ask? Because the list of FDA cGMP violations […]
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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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3 Tips to Handle Non-PDF Files in Your FDA eCopy Submission
April 3, 2013 Most people know that you can provide PDF files with your electronic eCopy submission (some hints on that here). However, the guidance points out that you also can create an eCopy that has files that are not PDFs. This is done by including Statistical Data or MISC Files folder at the root […]
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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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More Clarity Needed on FDA eSource Trial Data Draft Guidance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to Lab Compliance April 1, 2013 There are numerous calls among clinical trial stakeholders for more clarity on FDA draft guidance that tries to reduce pitfalls in switching to electronic source data for future clinical investigations.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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FDA/Customs Country of Origin Confusion on Drug Imports
Learn About PREDICT – FDA’s New Import Screening Program April 1, 2013 When drugs are imported into the US, there is a lot of information that needs to be reported to US Customs and to FDA. The information is collected and transmitted by computer, usually done by the importing company’s designated broker. One of the […]
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cGMP Quality Agreement Tip – Remember Definitions!
March 28, 2013 A cGMP quality agreement is a written contract that defines all of the quality parameters for a project and which of the parties is to be held accountable for each parameter. How detailed the quality agreement template is will depend upon which stage the drug or device product is in. Some of […]
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No Quality Agreement? You’re Asking for an FDA Warning Letter
7 Tips to Hire a Top GMP Consultant Dirty Business – Is GSK Pressure on FDA Influencing Hospira 483 Failures? March 28, 2013 FDA often sends warning letters to drug and device companies for not having a drug quality agreement with a contract manufacturing organization (CMO). Such a warning letter typically says something along the […]
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7 Tips to Hire a Top GMP Consultant
Is GSK Pressure on FDA Exacerbating Hospira 483 Mess? More Exclusive Expertbriefings News Upcoming Expertbriefings March 28, 2013 Due to all the layoffs in the pharma industry in recent years, we have seen a flood of new consultants in the pharmaceutical field. We’ve talked to quite a few experienced hands in the industry and this […]
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PDF Requirements a Critical Aspect of FDA eCopy
March 27, 2013 If you do not want your eCopy submission to be put on hold, you need to be really sure that you understand the FDA’s PDF requirements. And there are signs that many in industry are struggling with the stringent PDF requirements of eCopy. No matter if you select a volume or non-volume […]
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