Food and drug administration expanded access to treatment

Delamanid expanded access novel treatment of drug resistant tuberculosis

Tuberculosis (TB) remains a global emergency and is one of the most common infectious disease causes of death in developing countries. Current treatment regimens for multi-drug resistant TB are associated with low treatment success rates, are toxic, and require long duration of treatment. The need for shorter and more effective treatment regimens is urgent. Delamanid (Deltyba, or formerly known...

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...

Reply to the Food and Drug Administration Request for Comments

GSM-Based Wireless Database Access For Food And Drug Administration And Control

GSM (Global system for mobile communication) based wireless database access for food and drug administration and control is a system that enables one to send a query to the database using the short messaging system (SMS) for information about a particular food or drug. It works in such a way that a user needs only send an SMS in order to obtain information about a particular drug produced by a ...

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...