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Manufacturers › Canada › Food and Drug Administration (FDA)

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

Smart & Biggar

B.C. Supreme Court declines to strike Province’s class action claims to recover healthcare costs and damages related to opioid...

Smart & Biggar on

In August 2018, the Province of British Columbia (Province) commenced a class action on behalf of itself and other provincial and federal governments against approximately 50 pharmaceutical manufacturers, wholesalers, and...more

Arnall Golden Gregory LLP

A Guide to FDA’s Final Rule on the Importation of Prescription Drugs from Canada

Arnall Golden Gregory LLP on

On September 25, 2020, the U.S. Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)....more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Issues Proposed Policies to Facilitate Importation of Prescription Drugs from Canada, Other Countries

Akin Gump Strauss Hauer & Feld LLP on

• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada. • In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more

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