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Canada › Food and Drug Administration (FDA) › Final Rules

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

Jones Day on

The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

Goodwin

Canada, PhRMA and Others Challenge U.S. Prescription Drug Rules

Goodwin on

As we previously reported, in July 2019 the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (Action Plan) created with the FDA to allow the importation of certain prescription drugs...more

King & Spalding

FDA Finalizes Rule and Guidance to Implement Safe Importation Action Plan Aimed at Lowering Prescription Drug Prices

King & Spalding on

On September 24, 2020, FDA announced that it was taking action to help lower prescription drug prices by issuing a final rule and a final guidance aimed at facilitating the safe importation of certain prescription drugs....more

Foley Hoag LLP - Medicaid and the Law

CMS Weighs in on FDA Importation Rule

Foley Hoag LLP - Medicaid and the Law on

On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from...more

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