Analyzing the Global Regulatory Landscape and Approval Pathways for...

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2025-12-11 11:14:18 -

Analyzing the Global Regulatory Landscape and Approval Pathways for Gynecology Drugs

The Regulatory Landscape for women's health products is exceptionally stringent, given the sensitivity of the target population and the potential for long-term use (e.g., contraceptives). Approval pathways are governed by bodies such as the FDA (US) and EMA (Europe), which demand rigorous clinical trial data proving both efficacy and long-term safety, especially for hormonal and reproductive...

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