Sandoz Sues FDA Over Delay in First Biogeneric Approval  

Oleh:

Fox, Jeffrey L.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Nature Biotechnology: The Science and Business of Biotechnology vol. 23 no. 11 (Nov. 2005), page 1327-1328.
Topik: biotechnology; sandoz sues; FDA; biogeneric approval

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Perpustakaan Pusat (Semanggi) Nomor Panggil: NN9.4 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Officials at sandoz, the generic branch of novartis of basel, filed a rare type of lawsuit with the US district court on september 13. The company wants the court to force the US food and drug administration (FA) to rule on preferably, approve omnitrope its follow on version of recombinant human growth hormone (hGH). This case and its broader underlying issues could prove pivotal for how FDA regulates follow on protein products (also known as biogenerics). Indeed their collective fate could reshape the contours of the biotech industry. prominent members from both parties in congress are saying that new legislation may be need to fill the biogenerics policy gap at FDA, faster reviews leading to wider marketing of such products could help to contain health care costs.

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