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FDA publishes new draft guidance on animal drug compounding

USA - November 25 2019 As 2019 comes to an end, the United States Food & Drug Administration’s (“FDA” or the “Agency”) Center for Veterinary Medicine has published a new...

Emily L. Hussey, Kelly J. Kearney, David Hartmann.

FDA moves 10 bulk drug substances to Category 1 of the 503B categories of nominated substances

USA - November 12 2019 On October 31, 2019, the U.S. Food and Drug Administration (“FDA” or the “Agency”) moved ten bulk drug substances to Category 1 of the Agency’s list...

Emily L. Hussey, Kelly J. Kearney.

The Drug Enforcement Administration amends regulations applicable to registrants ordering certain controlled substances

USA - October 24 2019 The Drug Enforcement Administration (“DEA” or the “Administration”) recently published a notice in the Federal Register (volume 84, number 189, pages...

John D. Kendzior, Kelly J. Kearney.

FDA Partners with the National Association of Boards of Pharmacy to Create an Information-Sharing System for Drug Compounding Activities

USA - October 7 2019 On October 2, 2019, the United States Food & Drug Administration (FDA) announced that it awarded a cooperative agreement grant to the National...

Emily L. Hussey, Kelly J. Kearney.

Outsourcing Facility Athenex Withdraws Appeal of District Court’s Ruling on FDA’s Placement of Bulk Drug Substances on its “Clinical Need” List

USA - September 27 2019 On September 23, 2019, New York-based outsourcing facility Athenex, Inc. (Athenex) withdrew its appeal of the U.S. District Court for the District of...

Emily L. Hussey, Kelly J. Kearney.