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Source: ONE News -
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US health regulatory staff have questioned whether there are enough data to show that Female Health Co's latest version of its condom for women prevents pregnancy and sexually transmitted diseases, according to documents released.
The Chicago-based company is seeking Food and Drug Administration approval to sell its FC2 Female Condom to prevent pregnancy and HIV.
The company said it did not conduct clinical trials to show how well it prevents such outcomes because FC2 uses a new material but works the same way as the original version already on the US market, the FDA staff said. Instead, the company compared the new version with the older one.
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