We tested a novel hydrogen peroxide cleaner disinfectant formula concentrate (hereafter the "formula") against standardized EN test methods to determine if the formula was capable of meeting the European efficacy standards for Healthcare disinfection.
Finally, despite the lack of established efficacy standards for predicting the success of treatment with tigecycline, our findings confirmed and extended previous observations of high in vitro activity against Enterobacteriaceae (E. coli, 100% susceptible; Enterobacter, 98.4% susceptible; ESBL-positive K. pneumoniae, 97.9%) and also A. baumannii (94.4% susceptible at ≤ 2 mg/L) [ 16].
And we should not let a reduction of safety and efficacy standards replace our demand for safer and more effective treatments.
It should be noted, further, that success criteria for current efficacy standards are arbitrary and not based on clinical outcomes [ 8, 9].
Finally, an awareness of this pressing time burden strengthens arguments for constant critical appraisal of the efficacy for standard – often time consuming – self-management tasks.
A recent study demonstrated equal efficacy for standard and low dose interferon therapy (Tannir et al, 2006).
Provided it meets all the FDA standards for safety, efficacy and customer comprehension, the drug could be on the market next year.
New herbicides will not be commercialized within the near future, due to the increased development costs and the challenge to find suitable substances that comply with the stricter regulatory standards for weed efficacy and environmental and toxicological safety [6].
In fact, antibody preparations in the form of serum therapy were used historically for the treatment of anthrax (13), tularemia (49), and plague (37), albeit in uncontrolled trials that do not meet modern standards for establishing efficacy.
Judy Leon, a spokeswoman for the F.D.A., said the agency sympathized with patients but that it was necessary for drugs to meet agency standards for safety and efficacy.
"For us, there are certainly concerns about … the misperception that you might be able to speed innovation by lowering standards for safety and efficacy, and we think that would be a terrible mistake," said former FDA commissioner Margaret Hamburg at a National Press Club event, just before stepping down from her post in April.
