Food and Drug Administration's Obesity Drug Guidance Document: a short history.

Obesity Food and Drug Administration’s Obesity Drug Guidance Document A Short History

An estimated 70% of adult men and 60% of adult women in the United States are overweight or obese.1 Excess body fat increases the likelihood of developing hypertension, dyslipidemia, and type 2 diabetes mellitus and is an independent risk factor for cardiovascular disease.2–4 Obesity is linked to an increased risk for certain cancers, osteoarthritis, and sleep apnea.5–8 Obese people are stigmat...

Implications of the new Food and Drug Administration draft guidance on human factors engineering for diabetes device manufacturers.

This article discusses the implications of the new Food and Drug Administration's draft guidance on human factors and usability engineering for the development of diabetes-related devices. Important considerations include the challenge of identifying users, when the user population is so dramatically broad, and the challenge of identifying use environments when the same can be said for use envi...

A Roadmap for the Implementation of Continued Process Verification.

UNLABELLED In 2014, the members of the BioPhorum Operations Group (BPOG) produced a 100-page continued process verification case study, entitled "Continued Process Verification: An Industry Position Paper with Example Protocol". This case study captures the thought processes involved in creating a continued process verification plan for a new product in response to the U.S. Food and Drug Admini...

Current status of the sunscreen regulation in the United States: 2011 Food and Drug Administration's final rule on labeling and effectiveness testing.

ANPR: Advance Notice of Proposed Rulemaking CW: critical wavelength FDA: Food and Drug Administration MED: minimal erythema dose PPD: persistent pigment darkening SPF: sun protection factor TEA: Time and Extent Application INTRODUCTION On June 17, 2011, the US Food and Drug Administration (FDA) issued its long awaited final ruling on labeling and effectiveness testing of sunscreen products in t...

The food and drug administration's certification of antibiotic drugs for human use.