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Through years of research and analysis of customer needs , Internet Security Systems realizes that the convergence of security technologies into protection systems is the vision that will meet the growing demand for security effectiveness , and provide organizations with a smarter , easier-to-use and more manageable protection platform for desktops , servers and networks . But , as a handful of suicide bombers armed with no more than knives and box-cutters have shown with such devastating effectiveness , all this means precisely nothing . Because more often than not there is a lack of evidence of safety or effectiveness , ( rather than definitive evidence showing that a product is unsafe or ineffective ) , this will be an extremely difficult burden for the Agency to meet . Recent work by Haufmann , Kraay , and Zoido-Lobaton ( 1999 ) has developed aggregate indicators of six different aspects of governance-voice and accountability , political instability and violence , government effectiveness , regulatory burden , rule of law , and graft-showing that all of these are significantly associated with income levels in the expected manner . The risk is that a manufacturer will determine that a change does not affect safety or effectiveness , when in fact , it does . To establish with reasonable certainty that process differences and changes have not affected a protein product 's safety or effectiveness , both innovator and follow-on manufacturers must rely not only on testing and characterization of the final product , but also on extensive development experience with the product , in-process testing , toxicology studies , in vivo pharmacokinetic and pharmacodynamic studies , and reagents and reference standards that are not typically available to another manufacturer . At any stage of the clinical or animal studies , if data raise significant concerns about either safety or effectiveness , FDA may request additional information or studies or may halt ongoing studies . We might quibble with them ; we might question their appropriateness or effectiveness , but it is a much , much broader subset of policies that now affects every section of the United States , every region , with the exception of the South East . TSA is also revising existing screening procedures and developing new procedures to enhance security effectiveness , many of which are risk-based , as we have previously advocated . It focuses on four components of quality — effectiveness , patient safety , timeliness , and patient centeredness — and four components of access — getting into the health care system , getting care within the system , patient perceptions of care , and health care utilization .