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Pharmacies Win Remand Of FDA's Compounded Drug Memo

A D.C. federal judge on Tuesday ordered the U.S. Food and Drug Administration to either perform an analysis of its memorandum that created new regulations to fully implement a decades-old rule governing pharmacy compounding, or certify that the memo won't greatly impact small businesses, like the pharmacies challenging the memo. ....

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Standardizing the naming of cell based substances


The World Health Organization (WHO), as part of its International Nonproprietary Names (INN) system, has recently made progress in developing and harmonizing the definition paragraphs that support the naming of cell-based substances.
Those efforts are reflected in a newly revised INN application form for cell therapy substances, which was officially approved during the 70th INN Consultation in April 2020.
That version is now mandatory for all new INN applications for gene therapy (GT), cell therapy (CT) and cell-based gene therapy (CGT) substances.

The work was initiated based on the large volumes of cell and gene therapy applications the WHO was seeing in relation to INN requests,”​ Massimo Dominici, medical oncology expert, CEO of Rigenerand, and a member of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations serving the INN Expert Group, told us. ....

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