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Week of May 6th 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 12 new warning letters this week. Among the ones we cover one to a finished pharmaceutical firm. Want to see the complete list of enforcement documents — including recalls, alerts, and import alerts from this week? Start your FREE trial of the GMP Regulatory Newsletter today. Goran Pharma [...]

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GMP Regulatory Newsletter: Summary Scan | Week of 5/6/18

Laws, Regulations, Guidance, and Concept Papers A collection of both draft and final guidance: The FDA and EMA published this week Others also issued guidance including WHO, HPRA, Health Canada, TGA, and CDSCO.  Much to read! Also, the non-guidance publications continue: MHRA, EMA, and FDA published Among this later [...]

By | May 15th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|0 Comments

Week of Apr 29th 2018 | FDA Sent These Warning Letters to Pharma Companies

The FDA and Federal Trade Commission issued 13 warning letters this week to manufacturers and retailers selling e-liquids used in e-cigarettes. One of the objections was that the packaging resembles kid-friendly food products; others included selling these items to minors. FDA published 1 warning letter to a compounding pharmacy. [...]

GMP Regulatory Newsletter: Summary Scan | Week of 4/29/18

Laws, Regulations, Guidance, and Concept Papers Guidance documents were in modest supply this week: 4 from FDA 4 from EMA 2 from Health Canada 2 items from Pakistan FDA also withdrew 1 final rule due to “significant adverse comments” received during the comment period ending April 11th 2018. This [...]

By | May 8th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|0 Comments

Week of Apr 22nd 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 6 new warning letters this week: The Center for Tobacco issued 3 of them 1 warning letter went to an API manufacturer 2 warning letters were issued to finished pharmaceuticals manufacturers of OTC products DRUGS: Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd (Yunnan, China) received a warning [...]

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