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1 obustness of the vaccine approval system and postmarketing surveillance.
2 se complications will likely require careful postmarketing surveillance.
3 reported to Merck, the manufacturer, through postmarketing surveillance.
4 However, few data are available on postmarketing surveillance.
5 and reinforce the critical need for ongoing postmarketing surveillance.
6 s for transcatheter aortic valve replacement postmarketing surveillance.
7 entiary regulatory standards, development of postmarketing surveillance, a focus on clinically meanin
9 lestra (sucrose polyester) called for active postmarketing surveillance because preapproval studies s
11 data submitted to Merck from routine global postmarketing surveillance, combined with information fr
13 r examining the available literature and the postmarketing surveillance data, proposed a clinically b
19 e US Food and Drug Association (FDA), little postmarketing surveillance exists to assess real-world r
22 these issues, data from clinical trials and postmarketing surveillance have been evaluated extensive
23 recent studies have examined how frequently postmarketing surveillance identifies important ADRs.
26 tinue through clinical trials, and extend to postmarketing surveillance of ADRs in real-world populat
29 ition, observational studies can be used for postmarketing surveillance of new cancer treatments, par
32 (VAERS) is the passive reporting system for postmarketing surveillance of vaccine safety in the Unit
33 ministration mandated that companies conduct postmarketing surveillance (PMS) studies of approved ste
34 fety issues were identified through existing postmarketing surveillance programs and were of limited
37 and the importance of internationally robust postmarketing surveillance strategies as crucial compone
38 n the near future, with a call for effective postmarketing surveillance studies for all of the new en
42 that the agency's drug review procedures and postmarketing surveillance system after a drug has been
43 Administration (FDA) is building a national postmarketing surveillance system for medical devices, m
44 limited premarketing data are balanced with postmarketing surveillance to capture rare adverse event
45 This study demonstrates the power of active postmarketing surveillance to identify or exclude events
46 authorisation procedures mandated increased postmarketing surveillance to monitor vaccine safety.
47 es as applied to preclinical drug safety and postmarketing surveillance with a specific focus on mach