News & Analysis as of

India Imports Prescription Drugs

McGuireWoods LLP

FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

McGuireWoods LLP on

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more

Morgan Lewis

Important Clarifications in the Federal Circuit Acetris Decision

Morgan Lewis on

In addition to standing behind the plain language of the definition of a “US-made end product,” the court in Acetris Health, LLC v. United States provided new guidance regarding limits on Customs and Border Protection...more

Pillsbury Winthrop Shaw Pittman LLP

Substantial Transformation of the FAR Trade Agreements Clause

The Court found the disqualification of an offeror from a pharmaceutical procurement was in error based on a U.S. Customs and Boarder Protection (CBP) interpretation of the Trade Agreements Act of 1979 (TAA)....more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Revolutionizes Country of Origin Analysis for Pharmaceuticals

The Federal Circuit Court of Appeals has just rejected the longstanding U.S. government position that the country of origin of pharmaceuticals in the context of U.S. government procurement is determined by where the active...more

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