DRUG APPROVAL PROCESS: A CONTRASTIVE APPROACH

A New Approach to Psychiatric Drug Approval in Europe

Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value whereby evidence from studies comparing a new product with an active comparator should guide the drug approval process. Please see later in the arti...

From idea to market: the drug approval process.

BACKGROUND Each year many new prescription drugs are approved by the Food and Drug Administration (FDA). The process of developing and bringing new drugs to market is important for primary care physicians to understand. METHODS We describe the drug development process based on a review of the literature and Web sites addressing FDA processes and policies. RESULTS The process starts with pre...

Pharmacogenomics: tailoring the drug approval process for designer drugs.

the impact of portfolio assessment on iranian efl students essay writing: a process-oriented approach

this study was conducted to investigate the impact of portfolio assessment as a process-oriented assessment mechanism on iranian efl students’ english writing and its subskills of focus, elaboration, organization, conventions, and vocabulary. out of ninety juniors majoring in english literature and translation at the university of isfahan, sixty one of them who were at the same level of writing...

Drug approval and drug effectiveness.

Data on the efficacy and safety of psychiatric medicines should form the foundation of evidence-based treatment practices. The US Food and Drug Administration (FDA) reviews such data in determining whether to approve new treatments, and the published literature serves as a repository for evidence on treatment benefits and harms. We describe the FDA review of clinical trials, examining the under...