FDA draft guidance on compounding animal drugs from bulk drug substances: a commentary

FDA draft guidance on computerised systems used in clinical trials.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 This article discusses these issues and a draft guidance document.

Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA Reviewers

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...

Repurposing FDA-approved drugs to combat drug-resistant Acinetobacter baumannii.

OBJECTIVE The rising occurrence of drug-resistant pathogens accentuates the need to identify novel antibiotics. We wanted to identify new scaffolds for drug discovery by repurposing FDA-approved drugs against Acinetobacter baumannii, an emerging Gram-negative nosocomial drug-resistant pathogen. MATERIALS AND METHODS In this study, we screened 1040 FDA-approved drugs against drug-susceptible A...