Food and Drug Administration, Partner in Drug Development

The Food and Drug Administration and the Future of Drug Development for the Treatment of Diabetes.

The U.S. Food and Drug Administration (FDA) regulates the marketing of drugs in the United States. The FDA staff faces substantial challenges in evaluating preclinical and clinical trial data for a proposed new drug and deciding whether the resultant benefit-risk assessment supports marketing approval. Any approval decision will be associated with uncertainty regarding the drug's true risks and...

New food safety initiatives in the Food and Drug Administration.

Concern over the presence of veterinary drug residues in food has been increasing world wide. Because of this concern the Food and Drug Administration's Center for Veterinary Medicine (CVM) has been involved on an international basis in efforts to develop food safety standards for veterinary drugs. The major thrust of the Codex Committee on Residues of Veterinary Drugs in Foods (CC/RVDF) has be...

Food and Drug Administration regulation of food safety.

Mathematical Modeling and Lyapunov-Based Drug Administration in Cancer Chemotherapy

In this paper a new mathematical model is developed for the dynamics between tumor cells, normal cells, immune cells, chemotherapy drug concentration and drug toxicity. Then, the theorem of Lyapunov stability is applied to design treatment strategies for drug protocols that ensure a desired rate of tumor cell kill and push the system to the area with smaller tumor cells. Using of this theorem a...

Clinical evidence supporting pharmacogenomic biomarker testing provided in US Food and Drug Administration drug labels.

IMPORTANCE Genetic biomarkers that predict a drug's efficacy or likelihood of toxicity are assuming increasingly important roles in the personalization of pharmacotherapy, but concern exists that evidence that links use of some biomarkers to clinical benefit is insufficient. Nevertheless, information about the use of biomarkers appears in the labels of many prescription drugs, which may add con...