Bringing Safe and Effective Cell Therapies to the Bedside  

Oleh:

Preti, Robert A.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Nature Biotechnology: The Science and Business of Biotechnology vol. 23 no. 7 (Jul. 2005), page 801-804.
Topik: CELL; safe and effective cell; therapies; bedside

Ketersediaan

Perpustakaan Pusat (Semanggi) Nomor Panggil: NN9.3 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

New rules to assess the safety and efficacy of human cell and tissue based products are the culmination of a multiyear, cooperative effort between the US government and the biotech industry. With relatively little fanfare. The current good tissue practices (cGTP) final rule finally came into force in the united states in may. Under its legal authority, the US food and drug administration (FDA) now inspects entities involved in manufacture of human cells, tissues and cellular and tissue based products (collectivelly refered to as human cell / tissue based products from hereon) and ensures cGTP compliance. Although cellular medicines present formidable challenges to regulators. I argue here that the FDA's new regulation strikes the right balance between safety and encouragement of the development of new experimental medicines for unmet needs.

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