Editor’s Note: On Oct. 17, the U.S. District Court for the District of Columbia held that the Food and Drug Administration (FDA) lacked the statutory authority to require drug companies to study drugs in children, and the court overturned the FDA’s Pediatric Rule. As of January 2002, the Best Pharmaceuticals for Children Act (BPCA) has offered financial incentives to pharmaceutical companies that voluntarily study their drugs in children. The Pediatric Rule went one step further, imposing requirements on companies not doing pediatric testing of drugs approved for adult indications when the drug was highly likely to be used for comparable pediatric indications. Citing metabolic and pharmacokinetic differences between adults and children, many medical experts underscore the need for pediatric drug testing and formulations appropriate for children in all drugs likely to be prescribed to children.
סל התרופות כמו אקמול לחולה סרטן/ מאמר אורח מאת ד”ר אודי פרישמן
אין תגובות06/01/2020
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