نتایج جستجو برای: label and off
تعداد نتایج: 16854048 فیلتر نتایج به سال:
In regulating the promotion of unapproved, or off-label, uses of approved drugs, the Food and Drug Administration (FDA) has sought to strike a balance between supporting the ability of physicians to prescribe according to their best clinical judgment and preventing drug manufacturers from inappropriately driving prescribing practices. The agency has long maintained the general position that alt...
The US Food and Drug Administration's ('FDA' or the 'Agency') current regulatory framework for drug promotion, by significantly restricting the ability of drug manufacturers to communicate important, accurate, up-to-date scientific information about their products that is truthful and non-misleading, runs afoul of the First Amendment and actually runs counter to the Agency's public health missi...
Pediatric health research and development (R&D) has long lagged behind health R&D for adults. Methodological and ethical challenges associated with pediatric research increase the costs of running pediatric trials, and the market for pediatric products is relatively small. The subsequent knowledge gaps and lack of child-specific product development have resulted in high off-label and unlicensed...
Despite widespread therapeutic needs, the majority of medical and surgical devices used in children do not have approval or clearance from the Food and Drug Administration (FDA) for use in pediatric populations. The clinical need for devices to diagnose and treat diseases or conditions occurring in children has led to the widespread and necessary practice in pediatric medicine and surgery of us...
The authors have stated that the accuracy of dose was checked from standard neonatal formularies, viz. British National Formulary 2005 and Neofax 2008, and stated that 75% of medications were not approved by FDA for neonatal use. They have not mentioned the document or the source that they relied upon to classify the drug as off-label or otherwise. It may not be advisable to decide if use of a ...
Professor O'Reilly's study of recent drug review legislation applies a historical and holistic view of promotion practices for unapproved uses of prescription drugs. He faults Congress for moving public health protections away from a strictly protective mode and toward assistance to drug marketers. He argues that the adverse health consequences of "off-label" promotion of drugs are not well und...
Fueled by massive settlements and concerns about pharmaceutical company influence over medical practice, the fight over off-label promotion has become a rancorous one with little middle ground. For some, off-label restrictions are both bad law and bad medicine, violating the First Amendment while denying physicians access to crucial information. For others, the battle pits the very soul of the ...
Pediatric health research and development (R&D) has long lagged behind health R&D for adults. Methodological and ethical challenges associated with pediatric research increase the costs of running pediatric trials, and the market for pediatric products is relatively small. The subsequent knowledge gaps and lack of child-specific product development have resulted in high off-label and unlicensed...
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