INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 939 R I. THE IMPORTANCE OF DEFERENCE . . . . . . . . . . . . . . . . . . . . . . . . . 941 R II. THE PARTICIPANTS IN THE DEFERENCE DEBATE . . . . . . . . . . . . 942 R III. THE SUPREME COURT’S DEFERENCE TO THE FDA . . . . . . . . . 943 R IV. THE TYPES OF DEFERENCE ENJOYED BY THE FDA . ...

The Food and Drug Administration issued draft guidances in January that tackled health care economic information and product labeling. Do these publications indicate a potential shift in on- and off-label policies for drugs and devices?

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current...

The Food and Drug Administration, concerned about the quality of the generic drugs that represent 84 percent of U.S. prescriptions, is looking more closely at foreign manufacturing plants and weighing other changes in the generic approval process.

• The European Medical Agency (EMA) has issued regulatory guidelines for the development of biosimilar insulins that emphasize pharmacokinetic/pharmacodynamic studies rather than efficacy evaluations. In the United States, biosimilar insulins are currently covered by the Food and Drug Administration’s (FDA) 505(b)(2) pathway permitting evaluation of the reference product. Current and Future Per...

Detecting carbapenem-resistant Enterobacteriaceae (CRE) can be difficult. In particular, the absence of FDA-cleared automated antimicrobial susceptibility test (AST) devices that use revised Clinical and Laboratory Standards Institute (CLSI) carbapenem breakpoints for Enterobacteriaceae and the lack of active surveillance tests hamper the clinical laboratory. In this issue of the Journal of Cli...

aCenter for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, Maryland; bDivision of Nutrition, Physical Activity, and Obesity, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia; cPregnancy and Perinatology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Devel...

There's little study-based evidence of anyone getting gray hair from dyeing his or her hair over and over again. However, some studies have suggested that heavy use of hair dye might cause cancer [2] in some people (both in people who are dyeing their hair, and in colorists whose livelihood depends upon providing the coloring process). The connection to cancer needs more research, but it's enou...

Biosimilars, although not identical to their originator product, are expected to become essential in reducing health care costs and improving access to lifesaving drugs. The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cost-efficient way to expedite approvals of these products.