The U.S. Food and Drug Administration issued guidance for the Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, and Prescription Drugs. The document establishes initial […]
The U.S. Food and Drug Administration (FDA) is sticking to its timeline for implementation of the Drug Quality and Security Act (DQSA). According to IWLA Washington Representative Pat O’Connor: The […]
IWLA has been working with others in the Device Distribution Group to develop uniform licensing of 3PLs in the medical device supply chain. This legislation is designed to mirror the […]
The U.S. Food and Drug Administration recently released recommendations in question-and-answer format for the purposes of clarifying the Drug Quality Security Act. However, several contradictions in the state and federal […]
In a letter sent Sept. 9, U.S. Representative Fred Upton (R-Mich.), chairman of the House Committee on Energy and Commerce and author of the U.S. Food and Drug Administration (FDA) […]
Planning for the September 17-19 IWLA Legislative Fly-in is in full swing. Members from across the United States come to Washington, D.C., for three days of regulatory and legislative discussions […]
IWLA has been closely engaging the California Board of Pharmacy after issuance of AB 2605, a statewide pharmaceutical licensing requirement on third-party logistics providers. IWLA members fully support licensing standards […]
The U.S. Food & Drug Administration recently issued its first guidance under the Drug Supply Chain Security Act seeking public comment on its proposal for how prescription drug supply chain stakeholders should […]
The U.S. Food and Drug Administration is hosting a public workshop focused a critical part of the Drug Quality and Security Act. The “Standards for the Interoperable Exchange of Information for […]
The California Assembly Committee passed AB 2605 on April 29. The bill imposes a statewide licensing requirement on third-party logistics providers in the pharmaceutical supply chain. The legislation is inconsistent with […]
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