Abstract As more information about the potential risks and complications related to breast implants has become available, United States Food Drug Administration (FDA) responded by implementing changes improve patient education, recalling certain devices updating recommendations for screening silicone implant rupture. In addition staying up-to-date with FDA actions guidance, radiologists need ma...

The US Food and Drug Administration (FDA) receives millions of postmarket adverse event reports for drug therapeutic biologic products every year. One the most salient issues with these submissions is report duplication, where an experienced by one patient reported multiple times to FDA. Duplication has important negative implications data analysis. We improved optimized existing deduplication ...

n 1958, Congress enacted the Food Additives Amendment (FAA) to the Federal Food, Drug, and Cosmetics Act amid growing concern over the safety of substances added to foods. The FAA set forth standards and guidelines by which the safety of food additives must be established before they can be added to foods (FAA, 1958). The FAA contained an exclusion provided by Congress for substances “generally...

CREB (cAMP responsive element binding protein) protein (CBP) and adenovirus E1A-associated 300 kDa (p300) are histone acetyltransferases, which necessary for multiple cellular processes. Thus, CBP/p300 promising potential antitumor targets. To date, despite various small molecule inhibitors of bromodomain (BRD) having been reported, no specific inhibitor was approved by U.S. Food Drug Administr...

Mobile applications provide limitless possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the Food and Drug Administration (FDA) has the authority to regulate a much broader spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory que...

The U.S. Food and Drug Administration (FDA), through the Center for Biologics Evaluation and Research (CBER)/Center for Drug Evaluation and Research (CDER), has long identified that the development of biopharmaceutical products is becoming increasingly challenging, and is inefficient and costly. The agency has also commented that superior product-development sciences are needed to address the c...

1136 The US Food and Drug Administration (FDA) is among the oldest agencies in the federal government. Its origins can be traced back to 1862, when President Abraham Lincoln appointed a chemist, Charles M. Wetherill, to serve in the Department of Agriculture. One of the key early pieces of legislation that initiated the evolution of the FDA into its modern form was the 1906 Pure Food and Drug A...

NEW DRUGS Generic Desogestrel/Ethinyl Estradiol Contraceptives Watson Pharmaceuticals, Inc., has announced the final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for desogestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg, a generic version of OrthoMcNeil’s Ortho-Cept® and Organon’s Desogen®. These products are indicated for th...

The company 23andMe was founded ‘‘to help people access, understand and benefit from the human genome,’’ and in turn transfer genetic information from the lab to the home (23andMe, n.d.). Their Saliva Collection Kit and Personal Genome Service (PGS) gave consumers health reports on over 200 diseases along with their ancestry information. That changed when, on November 22, 2013, the Food and Dru...

The Food and Drug Administration (FDA) recently has re-released chymopapain, an injectable proteolytic enzyme used as an alternative to lumbar laminectomy in selected patients. The reported success rate, over 800%, has inspired an increasing usage of chymopapain. However, there is a reported 1 % incidence of anaphylaxis upon injection of this drug. The authors describe the means of early recogn...