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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

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Halting Europe’s essential medicines manufacturing exodus

European Pharmaceutical Review

The last paracetamol plant in Europe, closed in France in 2008 as it was no longer economically sustainable, marking the exit of paracetamol manufacturing from Europe” The closure of API manufacturing plants in Europe started in earnest 15 years ago.

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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. 2017; 55(7):1998-2008. References van Prehn J, Reigadas E, Vogelzang EH, et al. Clin Microbiol Infect. 2021; 27 (2): S1-S21. McDonald CL, Gerding DN, Johnson S, et al.

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Taming cardiovascular risk: the promise of LDL cholesterol lowering therapeutics

European Pharmaceutical Review

Even though patients are on existing [statins] that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death” We are recognising now is that there is great data on how to reduce risk by applying lipid lowering therapy like statins.

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Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

Feel free to use my own health timeline as a guideline to document your health journey. Thyroid hormones in relation to lead, mercury, and cadmium exposure in the National Health and Nutrition Examination Survey, 2007-2008. 2008 Nov;19(6):S207. Chen A, Kim SS, Chung E, Dietrich KN. Environ Health Perspect. 2013;121(2):181-186.

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Are Flame Retardant Toxins Contributing to Your Thyroid Condition?

The Thyroid Pharmacist

Breast milk and in-utero transmission have also been documented as a means for exposure and concern. [13]. Published September 4, 2008. While some flame retardants have been banned in the U.S. Human excretion of polybrominated diphenyl ether flame retardants: blood, urine, and sweat study. Biomed Res Int. Accessed November 14, 2020.