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Infectious Diseases

Gilead SEC filing confirms FDA warning letter on GMP concerns

This article was originally published in Scrip

Executive Summary

Gilead Sciences has stated in a US Securities and Exchange Commission filing that it has received a warning letter from the FDA concerning good manufacturing practice (GMP) deficiencies at its San Dimas, California, facility. Until the firm is able to correct the outstanding issues, Gilead says that it may be forced to curtail exports of its antifungal treatment AmBisome (amphotericin B).

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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