Regulating Off-Label Drug Use — Rethinking the Role of the FDA  

Oleh:

Stafford, Randall S.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 358 no. 14 (Apr. 2008), page 1427.

Ketersediaan

Perpustakaan FK Nomor Panggil: N08.K.2008.02 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

The Food and Drug Administration (FDA) provides a barrier to market entry and use of unproven and unsafe products. For prescription drugs, the FDA approval process requires substantial evidence of efficacy and safety for specific clinical situations. Although approval is indication-specific, the FDA has a limited role once a drug is on the market. Recent draft guidelines covering manufacturers' promotion of drugs through the distribution of journal articles suggest that the FDA is moving toward an even more minimal role.1 Although off-label prescribing — the prescription of a medication in a manner different from that approved by the FDA — . . .

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