FDA Issues Draft Guidance on Blood-Donor Deferrals

FDA draft guidance on computerised systems used in clinical trials.

When using computer systems to manage clinical studies, it is important to understand how these systems should be controlled and, for studies intended to support United States (US) regulatory submissions, when and how US regulations on electronic records and signatures apply. This article discusses these issues and a draft guidance document.

Blood donor deferrals: biting the hand that feeds us!

I n this issue of TRANSFUSION, the article by Zou and colleagues details trends in donor deferral and retention using the American Red Cross database. The power of the study is the enormous experience culled from almost half the nation’s blood supply. Prominent among the observations are the increasing deferrals for failing to achieve minimum hemoglobin (Hb)/ hematocrit (Hct) criteria and for d...

Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA Reviewers

Informal guidance and the FDA.

This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as its primary method of policymaking, as opposed to more formalized procedures like notice-and-comment rulemaking or case-specific adjudication. Using major developments in administrative law and modifi...

A Review of FDA Guidance

16.15.03-022010 Introduction Following publication of the December 2008 FDA Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes, assessment of cardiovascular safety has become a critical focus during the development of new antidiabetic therapies for Type 2 diabetes mellitus (T2DM). The importance of this guidance docume...