Disease relevance of Drug Approval

• Food and Drug Administration Drug approval summary: temozolomide plus radiation therapy for the treatment of newly diagnosed glioblastoma multiforme [1].
• FDA drug approval summary: pemetrexed for injection (Alimta) for the treatment of non-small cell lung cancer [2].

High impact information on Drug Approval

• The TPA controversy and the drug approval process. The view of the Cardiovascular and Renal Drugs Advisory Committee [3].
• Mitoxantrone and the new drug approval process [4].
• U.S. Food and Drug Administration Drug Approval Summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval [5].
• United States Food and Drug Administration Drug Approval summary: Gefitinib (ZD1839; Iressa) tablets [6].
• Zalcitabine (ddC) was the first drug to be approved under the US Food and Drug Administration's (FDA's) accelerated drug approval process [7].

Biological context of Drug Approval

• The OTC drug approval process. The ACG Committee on FDA-Related Matters. American College of Gastroenterology [8].

Associations of Drug Approval with chemical compounds

• In his book Deadly Medicine and on television, Thomas Moore impugns the process of antiarrhythmic drug approval in the 1980s, alleging that the new generation of drugs had flooded the marketplace and had caused deaths in numbers comparable to lives lost during war [9].
• As part of the drug approval process, a method is required for the confirmation of chloramine-T residues in edible fish tissue [10].
• Drug approval was based, in part, on data suggesting that beneficial changes in doxorubicin occurred in the absence of decreased therapeutic activity [11].
• FDA drug approval summaries: pemetrexed (Alimta) [12].
• U.S. Food and Drug Administration drug approval summaries: imatinib mesylate, mesna tablets, and zoledronic acid [13].

Gene context of Drug Approval

• The OTC drug monograph process and the NDA route of OTC drug approval are two different methods that reach the same result, the approval of safe and effective drugs [8].
• Postmarketing surveillance: curriculum for the clinical pharmacologist. Part I: Postmarketing surveillance within the continuum of the drug approval process [14].
• Drug approval often depends on a 75% improvement in the baseline PASI score, also known as a PASI 75 or Delta PASI 75 [15].
• Based on mechanistic approaches to the drug absorption and dissolution processes, the BCS enables the regulatory bodies to simplify and improve the drug approval process [16].
• Surrogate markers, such as CD4 counts and viral RNA levels, have been used recently in the anti-human immunodeficiency virus drug approval process with success [17].

Analytical, diagnostic and therapeutic context of Drug Approval

• FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension [18].

References