Resources

Laws, Regulations, Guidance, and Concept Papers It’s a very light week for new guidance documents, but do note that the FDA has two in the area of tobacco. The non-guidance publications include the usual collection from FDA, EMA, MHRA, HPRA, and TGA. The FDA also released the form 483 for a recent publication of Biocon’s […]

FDA posted six new warning letters this week including one to a compounding pharmacy and two to finished drug manufacturers. Both finished drug manufacturers are located outside the US. We address those below. Finished Drug Manufacturers: Zhejiang Ludao Technology Co., Ltd (Taizhou, China) received a warning letter on February 23th 2018 based on the outcome […]

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Laws, Regulations, Guidance, and Concept Papers It was a light week on the guidance front particularly from the EMA and the FDA. On the other hand: WHO published two drafts.Health Canada published a final revision to their drug GMPs.And, perhaps more important than all (I admit I’m prejudiced on the topic), is the final version […]

A blog entry that evaluated FDA enforcement actions in the first half of FY2016 provided data to demonstrate that the interval between GMP drug inspections and warning letters almost doubled since FY2013. The relevant table and graph is provided below. We’ve been watching this trend for the past couple of years, and now we are […]

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This past week, we added the following 483s to our database of 11,000+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. 483 3M Company Milford  Nov 2015 483 Accupack Midwest Cincinnati  Oct 2012 483 Advanced Interventional Pain Ctr IRB Lafayette  Oct 2013 483 AdvancePierre Foods Amherst  Mar 2011 […]

Laws, Regulations, Guidance, and Concept Papers FDA published four guidance documents this week: Two that address implementation of drug track and trace activitiesTwo that focus more on medical and safety The EMA published one item focused on inclusion of excipients in labeling. The non-guidance set of publications includes items from the EMA, FDA, MHRA, CDSCO, […]

A collection of warning letters were issued from the Center for Tobacco Products this week. In FY2017, the center issued 97% of all warning letters issued by the FDA. Also, the FDA issued one warning letter to a finished drug manufacturer and one to a device manufacturer. Both warning letters were issued to sites outside […]

  Semler Research Center Private Limited (Bangalore, India) is suing the FDA for requiring that sponsors repeat BA/BE studies based on the outcome of an FDA inspection that raised concerns about the trustworthiness and correctness of data. The legal complaint was filed January 18, 2018, in the US District Court Central District of California. The firm seeks […]