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Noncompliance Prescription Drugs Manufacturers

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

K&L Gates LLP

K&L Gates Triage: 340B Program: A Conversation with Chris Hatwig, Apexus President Part 2

K&L Gates LLP on

This is the second episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor under the 340B Program, including by providing technical...more

K&L Gates LLP

K&L Gates Triage: 340B Program: A Conversation with Chris Hatwig, Apexus President Part 1

K&L Gates LLP on

This is the first episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor in administering the 340B Program, including by publishing...more

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