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Proposed rule could allow certain prescription drugs to be imported from Canada; draft guidance explains how manufacturers could import drugs, biological products originally intended for sale in another country
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Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients.
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Access to affordable insulin can be a matter of life and death for Americans with diabetes. If not appropriately treated, diabetes can lead to serious and life-threatening complications, including heart disease, organ failure and blindness.
Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives.
PDUFA Target Action Date of June 2nd, 2020