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Tag: Pharma

Nov
07

It’s Official: Active Pharmaceutical Ingredient Makers in FDA’s Crosshairs

If there was any doubt whether the entire active pharmaceutical ingredient (API) industry is a target for continued FDA scrutiny, it should be gone. Donald Ashley, director of FDA’s Office of Compliance, talked about major concerns the agency has with the API industry at the Association for Accessible Medicines’ conference. As reported in an

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Aug
22

Recalls Remain Steady as Regulators are in the Hot Seat

The big story from the Q2 2019 Recall Index we’ve just released isn’t as much about the number of events or units recalled as it is the recall environment companies are finding themselves in. While Congress focuses on safety-related regulatory processes at the CPSC, and FDA tries to find its way on matters related to cannabis and CBD oil, companies are finding a regulator that is stricter and more sensitive to pressure from lawmakers.

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