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Pharmaceuticals / Regulatory Affairs

Questions Remain as FDA Moves to Streamline Insulin Approvals

May 23, 2019
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Acting FDA Commissioner Ned Sharpless said the agency is inching closer to bringing cheaper insulins to the market but that critical regulatory questions remain.

“We want to hear from you about what factors we should consider in evaluating information submitted by applicants for new biosimilar products,” Sharpless said, at an FDA-hosted public meeting on insulin biosimilars.

The FDA has until next March to begin regulating biosimilars such as insulin under the Public Health Service (PHS) Act—which covers approvals of most biologics—instead of under the Food, Drug and Cosmetics Act.

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