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FDA Warning Letters Drug Compounding FDA Approval

Fuerst Ittleman David & Joseph

FDA Issues Five Warning Letters to Makers of Knockoff GLP-1 Drugs

On December 17, 2024, the FDA published five (5) warning letters previously issued to makers of knockoff GLP-1 drugs. Four of the five warning letters were to companies (specifically, Xcel Research, Prime Vitality, Summit...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Warning Letter for Refusal to Permit Inspection: Important Takeaways for Startups and Drug and Device Manufacturers

Introduction: CGMPs and FDA Inspections - Current Good Manufacturing Practices (CGMPs) are mandated by regulations enforced by the U.S. Food and Drug Administration (FDA), and must be implemented and followed by...more

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