The potential for WNV transmission by blood transfusion during the acute phase of infection, when infected individuals are viremic and asymptomatic, was first recognized in 2002 (Ref. 2). At that time, test kit manufacturers and blood organizations, with input from the Public Health Service (National Institutes of Health, FDA, and Centers for Disease Control and Prevention CDC)) Full document...

This draft guidance document represents the Food and Drug Administration's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Full document...

The primary focus of this guidance is testing of "small molecule" drug substances, and not biologics as defined in the ICH S6 guidance. Full document...

The Food and Drug Administration (FDA) is issuing for public comment two draft guidances regarding L. monocytogenes in ready-to-eat (RTE) foods. Full document...

This guidance applies to somatic cellular therapy and gene therapy products. This guidance does not apply directly to human cells, tissues, and cellular and tissue products (HCT/Ps) which are regulated solely under Section 361 of the Public Health Service Act as described under 21 CFR 1271.10, or HCT/Ps which are regulated as medical devices under 21 CFR Part 820. Full document...

• Draft Compliance Policy Guide Sec. 555.320 Listeria monocytogenes
• Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods

This guidance is an annex to ICH Q8 Pharmaceutical Development and provides further clarification of key concepts outlined in the core guideline. In addition, this annex describes the principles of quality by design (QbD). Full document...