Importation

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

Pharmaceutical Industry Group Takes Legal Action Against Florida’s Prescription Drug Importation Program

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MIAMI, Florida – The Pharmaceutical Research and Manufacturers of America is reportedly preparing to file another lawsuit against Florida’s FDA-approved program to import prescription drugs from Canada, according to an unnamed source cited by Endpoints News. This legal action comes after the FDA recently approved Florida’s Canadian Prescription Drug Importation Program, a two-year initiative aimed at lowering drug prices for American consumers by importing certain prescription drugs from Canada. Under the program, Florida’s Agency for Health Care Administration must ensure the authenticity and compliance of the imported drugs with FDA standards. The program is being … Read more