In over a decade (2002 to 2012) of Staphylococcus aureus surveillance testing on 62,195 isolates, dalbavancin was demonstrated to be active against isolates that were either susceptible or nonsusceptible to daptomycin, linezolid, or tigecycline. Nearly all (99.8%) multidrug-resistant methicillin-resistant S. aureus isolates were inhibited by dalbavancin at ≤0.12 μg/ml (MIC50/90, 0.06/0.06 μg/ml...

Food control is essential for the benefit of local consumers as well as international trade, which impacts on the overall social and economic concerns of the nation. Nevertheless, success in food control implementation will not be achieved by a single agency. Concerned agencies as well as food industries have to be fully aware of and be responsible for the production of good quality and safe fo...

The establishment in 1995 of the World Trade Organization (WTO) and the adoption of international trade agreements pertaining to food regulation currently have a significant impact on domestic regulatory policies established by the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and other agencies responsible for protecting consumers and ensuring the safety of the...

The Food and Drug Administration (FDA or we) is issuing this final rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide scale public health harm. These food facilities are required to conduct a vulnerability assessment to identify...

The scope of further SPL development at this time is set by the U.S. Food and Drug Authority (FDA) in its mission to support existing and future drug labeling and drug listing regulations in the U.S. The most important scope-setter for major current SPL development is the so called “Physicians’ Labeling Rule,” that was announced as NPRM in 2000 and for which the release of the final rule is now...

Microbes continue to play a highly considerable role in the drug discovery and development process. Nevertheless, the number of new chemical entities (NCEs) of microbial origin that has been approved by the Food and Drug Administration (FDA) has been reduced in the past decade. This scarcity can be partly attributed to the redundancy in the discovered molecules from microbial isolates, which ar...