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Can rare disease research in the US thrive under the new administration?

Pharmaceutical Technology

Comstock said it is not yet clear if the report will be turned into an official agency guidance document, but it will be made publicly available. However, the PRV program for rare pediatric diseases is at risk of expiry in September 2026, and is pending renewal. Give your business an edge with our leading industry insights.

FDA
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Top 10 Journal Articles To Read During Your Infectious Diseases Pharmacy Rotation

IDStewardship

It’s from 2016 about the future of antibiotics and resistance, but it remains highly relevant today and people consistently give positive feedback about it. Memorizing 45+ page document is certainly not a reasonable expectation, but one can certainly walk away with an awareness of general concepts and themes which are relevant.

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STAT+: A ‘disaster’, or a ‘clear path’ forward?: New FDA guidance on AI in medicine sparks strong reactions

STAT

One medical device lawyer wrote that the document “violates” the 21st Century Cures Act passed by Congress in 2016 to exempt certain software products from regulatory review. But they are sharply divided on whether that’s a much-needed change, or a dramatic overreach by regulators.

FDA
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NICE recommends all-oral treatment for multiple myeloma

European Pharmaceutical Review

The final appraisal document (FAD) recommended the triple regimen as an option for adult patients who have received two or three lines of therapy. The National Institute for Health and Care Excellence (NICE) has recommended Ninlaro ® (ixazomib) with lenalidomide and dexamethasone for treating relapsed/refractory multiple myeloma (RRMM).

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Trial finds care home prescribing pharmacists improve drug burden index

Hospital Pharmacy Europe

Nevertheless, despite numerous studies employing a range of different interventions, a 2016 Cochrane review concluded that it was not possible to draw robust conclusions because of the variability in study designs, interventions, results and reported outcomes.

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RPS updates patient safety professional standards to reflect pharmacy evolution

Hospital Pharmacy Europe

The Royal Pharmaceutical Society (RPS) has published updated patient safety professional standards to reflect legislative, regulatory and national developments since the standards’ previous iteration in 2016. The post RPS updates patient safety professional standards to reflect pharmacy evolution appeared first on Hospital Pharmacy Europe.

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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. 2016; 46: 479–93. She worked at Cruces University Hospital focusing on pediatric brain tumours. References van Prehn J, Reigadas E, Vogelzang EH, et al. Intern Med J.