needed and that the current labeling requirements appropriately described the need for physicians to closely monitor transplant patient when using immunosuppressant drugs. Defs.’ Opp’n at 14-15 (citing Woodcock Letter at 13). As the defendants note, the FDA explained that “the current review process for ANDAs is adequate to assure the interchangeability of generic versions of immunosuppressant drugs such as tacrolimus with their branded counterparts.” Id. at 15 (quoting Woodcock Letter at 13). Accordingly, the FDA concluded that there was no need for the additional notices requested by the plaintiff. The “high degree” of deference afforded to the FDA in assessing scientific data applies to the FDA’s determinations regarding labeling requirements for drugs. See Henley, 77 F.3d at 620 (<HOLDING>); Biovail Corp. v. Food & Drug Admin., 519
recognizing that it is the proponents burden to demonstrate the admissibility of expert scientific testimony holding that the fda did not act in an arbitrary or capricious manner in refusing to require that a requested warning be placed on a drug label because the fdas determination of what labeling best reflects current scientific information regarding the risks and benefits of the drug involves a high degree of expert scientific analysis holding that graphology is accorded a low measure of scientific reliability in predicting character or state of mind and is not generally accepted in the scientific fields of psychology and psychiatry holding that expert opinion based on scientific technique is inadmissible unless technique is generally accepted as reliable in relevant scientific community holding that scientific hydrographic judgment and purely scientific considerations do not involve policy considerations and are not protected by the discretionary function exception