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Pharmaceutical Industry › Prescription Drugs › Noncompliance

Gardner Law

FDA Issues Numerous Warning Letters

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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

Womble Bond Dickinson

FDA Signals Reporting Requirements for Clinical Trials Enforcement with First-ever Notice of Noncompliance to Drug Maker

Womble Bond Dickinson on

On April 28, 2021, the US Food and Drug Administration (FDA) issued the first-ever Notice of Noncompliance after the drug maker did not comply with its legal reporting obligations for clinical trials upon earlier receipt of a...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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