On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib (Vioxx). On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. This represents the largest prescription-drug withdrawal in hi...

This article reviews the new beta-lactam (β-lactam) antibiotics doripenem, ceftobiprole, and ceftaroline. It covers pharmacokinetic and pharmacodynamic properties, dosing, in vitro activities, safety, and clinical trial results. Doripenem (Doribax) has been approved by the US Food and Drug Administration (FDA) for the treatment of complicated intra-abdominal and urinary tract infections. Ceftar...

Introduction According to the regulations and guidelines set by regulatory agencies, including the U.S. Food and Drug Administration (US FDA),1 the European Medicines Agency (EMA),2 extractable and leachable information must be included in applications for medical devices and container closure systems packaging for human drugs and biologics. The specific applications include the New Drug Applic...

Orphan drugs or drugs for rare diseases represents a particular regulatory conundrum. There is a desperate need for effective therapies for these patients, who have been historically underserved by the drug development community. However, there is also a need to make sure these therapies are both safe and effective. In response, the US Food and Drug Administration (FDA) has evolved new approach...

ABBREVIATIONS. FDA, US Food and Drug Administration; NDA, new drug application; PDR, Physicians Desk Reference; NME, new molecular entity; AAP, American Academy of Pediatrics; COD, Committee on Drugs; OPD, orphan products development; USP, US Pharmacopeia; USP-DI, US Pharmacopoeia–Drug Information; PhRMA, Pharmaceutical Research and Manufacturers Association; NIH, National Institutes of Health;...

Millions of dollars are spent each year in an effort to develop new medical devices designed to help individuals facing serious medical conditions. However, before these devices can reach consumers, they must be reviewed and cleared by the Food and Drug Administration ("FDA"). Innovative medical devices which pose the greatest risks and are aimed at helping the most critically ill consumers are...

The Drug Shortage Program at the Food and Drug Administration (FDA) is a division of the Center for Drug Evaluation and Research (CDER), one of the five centers within FDA. The four other centers include the Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, Center for Food Safety and Applied Nutrition, and Center for Veterinary Medicine. At the Drug Short...

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...