Nalbuphine-Naloxone Mix-ups; Compounding Pharmacy Registration with the FDA; FDA Draft Guidance

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...

FDA draft guidance on computerised systems used in clinical trials.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 This article discusses these issues and a draft guidance document.

Compounding Pharmacists Unhappy With New FDA Guidance Documents : Rules Severely Limit Distribution.

Recent FDA compounding guidances raise hackles.

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...

Pharmacy compounding of bioidentical hormone replacement therapy (BHRT): a proposed new approach to justify FDA regulation of these prescription drugs.