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Imports Draft Guidance

Hogan Lovells

FDA issues draft guidance on oversight of food products covered by Systems Recognition Arrangements

Hogan Lovells on

For the past several years, the U.S. Food and Drug Administration (FDA) has used a “Systems Recognition” approach with its foreign regulatory counterparts, through which the FDA evaluates whether its foreign counterpart...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FDA Issues Proposed Rule and Draft Guidance on Drug Importation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agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more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

• 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 • In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more

Akin Gump Strauss Hauer & Feld LLP

EU Trade Update

• European Commission publishes survey on concept of “Specially Designed for Military Use,” and issues request for input for possible EU commercial policy measures targeting the United States • Netherlands introduces...more

Jones Day

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 7

Jones Day on

USDA Inspector General Recommends Reform of AMS Organic Program for Imports - The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting...more

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