to the potential for dangerous levels of NDMA to develop in ranitidine. While the FDA investigated, voluntary recalls removed most over-the-counter ranitidine products from the market, but it was still available by prescription.
“We’re saying they aren’t defective but could become defective stored under stressful conditions for the product,” Woodcock said during the briefing. “I can’t recall anything exactly like this happening before.”David Light, CEO of Valisure, is glad ranitidine is being removed from the market, but he doesn’t believe the problem has been solved completely. “The FDA was originally focused on manufacturing, which I can understand,” he said.
The approvals process itself may change after this discovery. “This needs to be institutionalized and put into the ordinary testing of pharmaceuticals, so we don’t find out once they’re on the market that there’s a problem,” she said. Woodcock expects the FDA to be putting out guidance for the industry in the near future.
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