Cautious Welcome for FDA Pharmacogenomics Guidance  

Oleh:

Katsnelson, Alla

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Nature Biotechnology: The Science and Business of Biotechnology vol. 23 no. 5 (Mei 2005), page 510.
Topik: genomics; FDA; pharmacohenomics

Ketersediaan

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

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Isi artikel

The US Food and Drug Administration (FDA) on march 22 issued the long awaited final version of its guidance for industry on submission of pharmacogenomics data, giving industry a strong political signal that it is open to applications concerning therapeutic products personalized to patients genetic blueprints. The main challenge for the regulator is to encourage industry to submit voluntary data to help refine the pharmacogenomics approval process and speed up the arrival of the next wave of such products to the market.

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