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FDA Risk Evaluation and Mitigation Strategy (REMS) for Fentanyl Products

FDA Risk Evaluation and Mitigation Strategy (REMS) for Fentanyl Products

Dec 29, 2020 | News, Regulatory

The U.S. Food and Drug Administration (FDA) has made their REMS requirements for transmucosal immediate-release fentanyl (TIRF) products more rigorous to minimize inappropriate prescriptions for the strong and highly addictive opioid. The REMS guidelines serve as a...
FDA Allows Outsourcing for Drugs in Short Supply Due to COVID-19 Pandemic

FDA Allows Outsourcing for Drugs in Short Supply Due to COVID-19 Pandemic

Apr 17, 2020 | News, Regulatory

The FDA announced on Thursday (4/16) it was temporarily allowing compounding for necessary hospital drugs due to the mass shortage from COVID-19. The majority of the 13 commonly used drugs listed in the policy are anesthetic or analgesic drugs, which helps...

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