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Episode 908: Finally, All the VTE Recommendations In One Document!

Pharmacy Joe

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document.

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Episode 908: Finally, All the VTE Recommendations In One Document!

Pharmacy Joe

Episode 908: Finally, All the VTE Recommendations In One Document! This meant that any unchanged guidance statements from the 2012 9th edition were still considered to be part of the guidelines, but were not reprinted in the 2016 document.

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NICE recommends first licenced treatment for AL amyloidosis

European Pharmaceutical Review

NICE’s positive decision, which is detailed in the final appraisal document , follows an appeal against NICE’s original guidance from November 2022. The document highlighted that daratumumab in combination “increases the time until systemic AL amyloidosis gets worse compared with bortezomib plus cyclophosphamide and dexamethasone.”

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Whole genome sequencing and analysis of live biotherapeutic products

European Pharmaceutical Review

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. Therefore, characterisation of the microorganism(s) is of utmost importance to LBP quality documentation.

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Creating eBook Using Word

RX Note

Insert Page Number To start inserting page number, you can either double click header or footer section of the document, a new tab of "Header & Footer". You may tick on " Different First Page" if the document includes cover page. Save As the document and give a File Name Change the type to PDF Click the " Options."

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog: Biosimilars

This guidance, when finalized, will replace the original version of this document finalized in 2017. Based on a review of premarket submissions made in 2012 through 2019, FDA identified 90 examples of 510(k)s, De Novos, HDEs, and PMAs approved/cleared which utilized RWE in support of regulatory decision-making.

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FDA worried about Pfizer/Lilly pain drug safety ahead of key meeting

pharmaphorum

Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally lifted in 2015. Tanezumab is now the most developed of the two remaining drugs in development in the NGF class, in pain caused by osteoarthritis.