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Sunitinib is not approved for ABC, and Pfizer did not submit a request for regulatory review of sunitinib in ABC by the FDA or other regulatory bodies.
Many difficult questions are raised for regulators by requests for access to data arising in commercial clinical trials and residing within the agencies having been submitted by companies in support of a request for regulatory action.
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His financial contributions to, and requests for regulatory intervention from five sitting U.S. senators led to those legislators being dubbed "the Keating Five".
To reduce the chance of bias from differential discontinuation of participants between the tiotropium and placebo arms, retrospective mortality ascertainment on participants who discontinued the assigned intervention was carried out at the request of regulatory agencies for the two long term trials, after safety concerns about tiotropium.
An obscure request for comments on regulatory standards, released by the Office of the Comptroller of the Currency (OCC) last March, has since evolved into a complex turf war between the states and Washington, DC.
Better alignment between data requests from regulatory authorities and health technology assessment bodies is strongly recommended.
A fourth study was conducted with 2,4-dichlorophenoxyacetic acid (2,4-D) in response to a regulatory request for reproduction and developmental neurotoxicity data.
A Plains Pipeline spokesman did not immediately respond to a request for comment about its regulatory record.
In this study, the risk was observed only in patients with prior cardiovascular disease, and not in those at high cardiovascular risk (due to diabetes) but without prior cardiovascular disease, but the signal was sufficient for regulatory bodies to request withdrawal from the market.
Previously, Singapore (a member of both APEC and ICH) used to request for CPPs but as its regulatory system matured, the requirement for the CPP has been removed from both its pre- and post-marketing control requirements.
As a consequence, a virtually unlimited number of different nanomaterials can be identified, which may result in a burdensome request for a large amount of toxicological data for regulatory hazard assessment.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com