FDA

FDA Approves Groundbreaking Program Allowing Importation of Canadian-Approved Drugs Into the U.S.

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TALLAHASSEE, Fla. – The U.S. Food and Drug Administration (FDA) has recently approved a proposal that allows for the importation of Canadian-approved pharmaceuticals into the United States. This marks the first time that a program of its kind has been implemented, enabling a state to import drugs approved by a foreign regulator. The program, known as the Section 804 Importation Program (SIP), allows U.S. states or tribes to apply for approval to import drugs that were initially approved by Health Canada instead of the FDA. Florida is the first state to receive FDA approval for … Read more

FDA Program Allows Importation of Health Canada-Approved Drugs, Opening New Opportunities for Pharmaceutical Access

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Miami, Florida – The importation of drugs approved by Health Canada into the United States may become a reality under a new program established by the FDA. Recently, the FDA approved a proposal for the Section 804 Importation Program (SIP) in Florida, making it the first state to receive approval for importing pharmaceuticals approved by a foreign regulator. This groundbreaking move could pave the way for other states, like Colorado, to seek FDA approval for similar programs. While the availability of Canadian-approved drugs in the US is promising, it presents unique challenges for foreign manufacturers … Read more