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In the current US (or European) drug approval process for drugs for the treatment of benign prostatic hyperplasia (BPH) there is a strict policy requiring that all data supporting the safety and effectiveness of a new drug, have been published in a peer-reviewed, systematic review and clinical data published in a high quality, peer-reviewed journal. In the case of Nolvadex, this is a requirement for all approved drugs submitted for approval as a treatment for BPH. Furthermore, in the case of the latest drug approvals, no approval data is required to support the safety and efficacy of this drug beyond peer-reviewed, systematic review data and clinical data published in high quality, peer-reviewed journals [6].

Citation

Nolvadex: Prostate cancer treatment for men http://www.clinicaltrials.gov/ct2/show/NCT

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