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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 […]

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Laws, Regulations, Guidance, and Concept Papers The FDA issued a collection of guidance the week of February 18th regarding devices, safety, clinical ICH Quality, and administrative items. WHO and TGA each published two new guidance. It was a busy week on the publication front. Enforcement Enforcement included two warning letters, one to a device firm […]

The FDA posted 6 warning letters this week, and we cover 5 of them below. One went to a device firm, and 4 went to finished pharmaceuticals sites, all located outside the US. Medical Devices Curasan AG (Frankfurt Germany) site received a warning letter on August 23, 2017, based on the outcome of an inspection […]

Laws, Regulations, Guidance, and Concept Papers The week of February 11, 2018 was slow in the publication of guidance documents. The FDA published three, and the EMA did not publish any in the areas we follow. Health Canada and HPRA each published one item. There were also non-guidance documents and information published by EMA, MHRA, […]

The FDA published only seven warning letters this week. Of interest to us are two issued to finished drug manufacturers. The FDA continues their focus on OTC facilities that seemed to begin in 2017. Polaroisin International Co., Ltd. (Taiwan) received a warning letter on January 25, 2018, based on the outcome of an inspection ending […]

Here at FDAzilla, we’re excited to report that we have just collected our 20,000th FDA Warning Letter, going back to 2000, all completely searchable in our database.As you may know, the FDA automatically archives warning letters older than 5 years (and just did so with their 2012 collection last month). Yes it’s true: arguably, the […]

We took a snapshot of the 16 warning letters the FDA sent to pharmaceutical companies last month. The “Violation of the Month” was failing to bear adequate directions for the drug’s intended use. From pharmaceuticals in New Jersey, Japan, and more, here they are (starting with the most recent): Daito Kasei Kogyo Co.,Okayama,Japan – 2 violations:Failure to […]