Why the New FDA Glucose Meter POCT Guidance Is Disappointing

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...

Why Have Climate Negotiations Proved So Disappointing?

In this Issue: Focusing on POCT Glucose meter use in the intensive care unit: much ado about something

Corresponding autor: Brad S. Karon Department of Laboratory Medicine and Pathology Mayo Clinic 200 First Street SW Rochester, MN 55905 Phone: 507-538-4921 Fax: 507-538-7060 E-mail: [email protected] Disclosures: No financial support or conflicts of interest to disclose.

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...

Non-invasive Glucose Meter

Approximately 18 million people suffer from diabetes mellitus, also known as diabetes, only in the United States which is 5% of the total population. It is the seventh leading cause of death. By 2020, the cost associated with diabetic treatment is expected to rise as high as $192 billion (Freer, March 2011). There is no cure for diabetic till date. Measuring glucose level in a diabetic patient ...