1 Buprenorphine is a long‐acting opiate analgesic. This study was designed to investigate the pharmacokinetics of this drug when given by the sublingual route to ten postoperative patients. Plasma levels of buprenorphine were measured by a specific radioimmunoassay. 2 Plasma levels of the drug following sublingual administration of 0.4 mg showed an apparent delay in absorption and then rose slowly to reach low but significant levels by 3 h. There was considerable variation in the time at which peak levels were achieved. The average systemic availability of the drug by this route was estimated to be 30% by 3 h. 3 Analgesic efficacy and duration of sublingual buprenorphine were assessed using demand analgesia. The analgesia was of about 9 h duration, similar to that achieved by parenteral administration of 0.3 mg of the drug to an equivalent group of patients. The sublingual dose caused a significant fall in the postoperatively elevated group of patients. The sublingual dose caused a significant fall in the postoperatively elevated plasma glucose, and prevented any further rise in plasma cortisol. 4 Reasons for the efficacy of the sublingual route are discussed and it is suggested that this route may be particularly appropriate for highly lipophilic drugs like buprenorphine.

Toxic epidermal necrolysis (TEN) is a rare disease that is defined by extensive detachment of full-thickness epidermis. It most often is related to an adverse drug reaction. The drugs implicated in most cases of TEN have been sulfonamides, anticonvulsants, allopurinol, and some of the conventional nonsteroidal antiinflammatory agents. We describe a patient who developed a generalized desquamating rash after therapy with celecoxib.

The U.S. Food and Drug Administration (FDA) is the primary federal government agency that is responsible for protecting and promoting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biologics, medical devices, food, dietary supplements, cosmetics, tobacco, and products that emit radiation. To achieve this mission, the FDA balances the twin goals of assuring products are safe and effective and encouraging innovation and new product entry into the market. As a science‐based institution, the FDA also reviews clinical research, monitors the marketing practices of regulated‐industry to assure the public gets accurate, science‐based information, and interacts with international bodies with the goal of reducing the burden of regulation and harmonizing regulatory requirements. The FDA's organization currently consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency. Functionally, the FDA is comprised of six product centers: the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Veterinary Medicine (CVM), the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Tobacco Products (CTP). The FDA also has an office dedicated to research and multiple offices focused on global regulatory operations and policy. Collectively these Centers oversee the development, manufacture, promotion and distribution of drugs, biologics, veterinary products, medical devices, foods, dietary supplements, cosmetics, and tobacco in the United States under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations. This article provides a historical summary of the legal framework in which the FDA operates, discusses the FDA's organization and role, highlights the regulatory requirements for each of the product types the FDA regulates, and ends with a general discussion of the FDA's enforcement powers.

No abstract