FDA Draws Accusation Of Gender Bias Against FSD Drugs
This article was originally published in Pharmaceutical Approvals Monthly
Some commentators raised concerns that FDA was holding patient-reported outcomes for female sexual dysfunction to a higher standard than similar tools for erectile dysfunction.
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Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.
Part 1: Execs from rare disease-focused companies weighed in on investor sentiment during a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference.
Patients with the most severe type of disease were all randomized to treatment with the study drug, which may have had a negative impact on outcome, the Israeli company suggested.