How do pharmaceutical companies approach data from sexual health studies for regulatory agencies?

Article Abstract:

The process of bringing new drugs to market involves significant input from statisticians, not only through their involvement in clinical trial research but also through negotiations with regulators who provide guidance about the evidence necessary to convince government agencies, doctors, and patients that a particular drug is safe and effective for a particular disease. It is believed that only when a regulatory agency such as the Federal Drug Administration is persuaded that a drug is both safe and effective will it grant a license to market the drug.

Product development, Legal issues & crime, Government regulation (cont), Government regulation, Pharmaceutical preparations, Legal/Government Regulation, Laws, regulations and rules, Pharmaceutical industry, Market entry

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Sexual therapy in the age of pharmacotherapy

Article Abstract:

The effectiveness of combined medical and psychological intervention for the treatment of male sexual dysfunction is studied. Preliminary evidence indicates that combined treatment leads to improved efficacy of the medical interventions, decreased discontinuation rates, enhanced treatment and sexual satisfaction.

Psychological aspects, Health aspects, Care and treatment, Impotence, Sex therapy, Premature ejaculation

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