Administrator challenges

US Food and Drug Administration. Challenge and Opportunity on the Path to New Medical Products, March, 2004, http //www.fda.gov/oc/initiatives/critical-path/whitepaper.html... 

The challenges to implementing a modified baseline process are both technical and nontechnical. The committee believes that if the Army acts promptly, the necessary technical developments could be completed and demonstrated. Administrative challenges, which involve obtaining regulatory approval for various system options, also appear to be surmountable. All of the challenges are fully discussed in the report. 

Food and drug administration. Challenge and Opportunity on the Critical Path to New Medical Products, Innovation or Stagnation U.S. Department of Health and Human Services Washington, DC, 2004. 

Administrative challenges pose a limitation to the completeness of any integrated system. Creating integrated systems that extend beyond the boundaries of a single health maintenance organization to area hospitals, emergency departments, and... 

The more administratively challenging schedule is to operate on a 24-hr 7-day schedule. Clearly, this is the most efficient of all schedules because it uses all 168 hr in the week without stoppage. The elimination of stoppage itself is an added efficiency as there is always some lost time within the scheduled work program whenever a shutdown occurs. As an example, even in a 5-day 24-hr operation, as the end of the fifth (and final) workday there must be some lost time associated with the facility shutdown for the weekend, as well as time lost on the first day to restart the operation. 

In 1981, Chinese Restaurant Asthma was reported following capsule administration of MSG to several asthmatics (37). However, the researchers failed to account for other allergens to which the subjects could have been exposed and did not utilize the scientific practice of a "control" substance which would have helped to determine if glutamate triggered this response. In a double-blind crossover study, chronic asthmatics were challenged with MSG or a placebo. No decrease in pulmonary function was observed (39). 

The movement toward federal appliance efficiency standards stalled in the 1980s as the Reagan Administration, which opposed standards from an ideological perspective, began. That administration s approach was made evident by its refusal to finalize the DOE s 1980 standards proposal, and in 1983, by the issuance of a federal rule that determined that no standards were necessary. Both the delay and the no standard determination were challenged by NRDC, with the support of several large states, through the courts. 

Animals may not be moved for 14 days after administration of the experimental product, and records on the disposition of trial animals must be retained for 2 years. Bio-security issues will be of particular concern to the environmental impact assessment where trials involve live organisms or genetically modified organisms, either in vaccine challenge studies or as experimental products. 

Normal saline is an isotonic fluid composed of water, sodium, and chloride. It provides primarily ECF replacement and can be used for virtually any cause of TBW depletion. Common uses of normal saline include perioperative fluid administration volume resuscitation of shock, hemorrhage, or burn patients fluid challenges in hypotensive or oliguric patients and hyponatremia. 

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