FDAAAFood and Drug Administration Amendments Act
FDAAAFood and Drug Administration Alumni Association, Inc. (est. 2001)
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Hatch-Waxman Act and the FDAAA to examine the legislative origins of
[11] Another study carried out in the USA in 2014 after the introduction of the FDAAA in 2007 indicated an improvement in publication rates, with 118 out of 400 (29.5%) clinical trials failing to disseminate their results within 4 years of completion.
products." (53) A secondary proposal by the NIH suggests registration and reporting for all NIH-funded trials "regardless of study phase, type of intervention, or whether they are subject to the FDAAA requirements;" (54) however, as Jennifer Miller, a fellow at the Kenan Institute for Ethics at Duke University, observes, the impact of these initiatives may be limited since "oversight and enforcement by the FDA ...
The FDAAA also required the FDA to set up a website requiring food and pet food manufacturers, packers, processors, handlers, and marketers to report within 24 hours of determining that a food issue has a reasonable likelihood of causing a serious health concern.
(92) Notwithstanding expectations that the FDA would use its enhanced regulatory power under the FDAAA to more aggressively police postmarket drug use, the agency has demonstrated reluctance to realize the ambitious statutory mandate envisioned by Congress.
(123) Finally, Sharon Jacobs argues practically that the FDAAA, including its conflict of interest provisions, was reactionary legislation in response to the Vioxx scandal (124) and that its primary effect is little more than unnecessary red tape overburdening an already resource-strained agency.
FDAAA also created more severe punishments for violators of its transparency provisions.
Drug Safety Initiative and later required by FDAAA. (31) Its members
* 2007 - FDA Amendments Act (FDAAA) of 2007 - Numerous amendments to the FDC Act including the reauthorization and expansion of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA).