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1 without hemophilia has been increasing since licensure.
2  only to meet the visual acuity criteria for licensure.
3 ntil larger population exposures occur after licensure.
4  ameliorate viremia merits consideration for licensure.
5 d be evaluated in efficacy trials to support licensure.
6 if they possess properties required for drug licensure.
7  for driving outcomes 12 and 48 months after licensure.
8 AIT product to allow an informed decision on licensure.
9 ne design might yield a vaccine suitable for licensure.
10 at informed WHO prequalification and product licensure.
11 accine efficacy and potentially accelerating licensure.
12 didates and potentially useful in support of licensure.
13 ne effectiveness, and regulatory pathways to licensure.
14 , and/or being prescribed ADHD medication at licensure.
15  prescribed medication in the 30 days before licensure.
16 nd to detect potential changes since vaccine licensure.
17 ing exposure during their first 18 months of licensure.
18  for designing phase III trials and ultimate licensure.
19 B vaccines currently under consideration for licensure.
20 and are used to specify criteria for vaccine licensure.
21 , as no current vaccine candidate is nearing licensure.
22 zed to identify changes occurring after MCV4 licensure.
23 ations arise in clinical trials or following licensure.
24 e correlate of protection for recent vaccine licensures.
25 eiving US Food and Drug Administration (FDA) licensure 2005-2012 inclusive in seven neurological diso
26 s of HZ vaccine in healthy adults before its licensure, a series of strategies are proposed for evalu
27 provided efficacy data in support of vaccine licensure.A ZIKV CHIM could be instrumental in determini
28  demonstrating a higher risk of disciplinary licensure actions in physicians who did not maintain boa
29 d adult for a full year; followed by level 2 licensure, allowing unsupervised driving from 5 AM to 9
30  (CNC) rates during their first 18 months of licensure and (2) faster reduction in CNC rates over tim
31 ne receipt during the first RSV season after licensure and 21 or more days before LRTD event.
32                                      Between licensure and April 1999, the FDA received 15 reports of
33 training, and to examine reasons for delayed licensure and barriers to accessing training.
34  and future educational curricula as well as licensure and certification examinations.
35 field trials in Great Britain to support its licensure and commercialisation.
36          However, the result of more uniform licensure and credentialing may be excessive standardiza
37   However, many challenges to the successful licensure and deployment of an effective tuberculosis va
38                                     Rates of licensure and driving outcomes among youths who were lic
39                                    Since the licensure and generalization of an effective measles vir
40 ed States during the 25 years before vaccine licensure and identified 2262 people who died with varic
41                         Physicians' state of licensure and medical specialty were identified.
42                   This was supported through licensure and orientation to work, career and competence
43                                          Pre-licensure and post-licensure studies have provided data
44 as significantly advanced our efforts toward licensure and which has the potential to replace the PPD
45                                          The licensure and WHO prequalification of nOPV2 should be ac
46                         The data support the licensure and WHO prequalification of nOPV2.
47 y and immunogenicity data required for nOPV2 licensure and WHO prequalification.
48  of 15.0% had undergone an eye exam prior to licensure, and 3.4% had undergone an eye exam within the
49 view of clinical nurse specialist education, licensure, and certification requirements as well as a d
50 ns concerning advance directives and medical licensure, and literature concerning the fiduciary oblig
51  (26%) disclosed information about clinician licensure, and some used internationally based physician
52 dvance Shigella vaccine development, support licensure, and ultimately facilitate vaccine deployment
53                 Using this rule, pathways to licensure are being developed for new vaccines against b
54 t that current vision screening for drivers' licensure, based primarily on visual acuity, may miss im
55 o detect potential risks not observed before licensure because of the relatively small sample size an
56 ng boards, resident education accreditation, licensure boards, and hospital medical staff offices.
57 to the needs of payers and credentialing and licensure bodies and to demonstrate dermatologic value.
58 effects are commonly evaluated pre- and post-licensure, but more complex comparative evaluations have
59 stems to advance investigational products to licensure by conducting trials that de-risk private sect
60           These antitoxins were approved for licensure by the United States Food and Drug Administrat
61                                          Pre-licensure clinical studies showed that mean serum anti-V
62  (3) participation in the Interstate Medical Licensure Compact (IMLC), permitting psychiatrists to pr
63 cured outside the medical establishment, (2) licensure criteria for prescribers and therapists, (3) c
64  the second vaccine dose per US and European licensure criteria in the per-protocol cohort (n = 389).
65  overall (n=113), European influenza vaccine licensure criteria were fulfilled for responses to A/tur
66 logics Evaluation Research and Review (CBER) licensure criteria were met for all groups.
67  profiles (VE(SYMP) and VE(SUSC)) satisfying licensure criteria.
68  >/=70%, thus fulfilling the US and European licensure criteria.
69        Cross-sectional study using physician licensure data linked with administrative records on all
70 ines were excluded because little or no post-licensure data were available.
71 se trials that establish efficacy and inform licensure decisions or "real world" vaccine usage such a
72 n some regions, so vaccine efficacy and post-licensure effectiveness studies should assess the effect
73 al of Philadelphia network within 2 years of licensure eligibility at age 17 years.
74                           At 48 months after licensure eligibility, 75.5% (95% CI, 73.3%-77.7%) and 8
75                                     Eventual licensure enabling widespread access to phages is the go
76 ory oversight and licensure, policy and post-licensure evaluation, and post-licensure financing-and i
77 re within 6-18 months of passing their state licensure exam at the time of survey administration.
78  could feasibly complete both parts of their licensure examination between May 2007 and March 2011.
79                       Adjustment for medical licensure examination scores did not substantially alter
80 potentially adopting a USA based approach to licensure examinations and implementing necessary instit
81 licy and post-licensure evaluation, and post-licensure financing-and identify key stakeholders and sp
82 being considered to facilitate vaccine early licensure, followed by demonstration of efficacy assesse
83  ascertain immunological non-inferiority for licensure for alternate dosing schedules, bridging to ag
84             Efficacy trials that have led to licensure for cervical cancer prevention have used the d
85 nsing (GDL) systems allow full, unrestricted licensure for drivers younger than 18 years only after a
86      Trips at night, precipitation presence, licensure for less than 6 months, and sex were not assoc
87 r providing pivotal data for malaria vaccine licensure for travelers to Africa, and potentially for e
88 s are expected in the near future, including licensure for use in boys and men and the approval of a
89 onjugate vaccine (PCV13) was inferred before licensure from an aggregate correlate of protection esta
90  received emergency use authorization and/or licensure from the US Food and Drug Administration and t
91 nce has declined following varicella vaccine licensure, herpes zoster (HZ) cases may play a larger ro
92 ng, even if it were not required for driving licensure; however, only 62% reported always wearing the
93                                      The pre-licensure immunogenicity assessments of therapeutic prot
94                                    Since its licensure in 1995, the extensive use of varicella vaccin
95 ed Oka strain VZV vaccine (OkaVZV) since its licensure in 1995.
96 nce challenges predated varicella vaccine US licensure in 1995.
97                                        Since licensure in 2006, rotavirus vaccines have been introduc
98 in 2009 and mandated for Puerto Rico medical licensure in 2010.
99 up B meningococcal disease (IMD) since their licensure in 2013 and 2014.
100 umber of AIT products successfully obtaining licensure in the analogous time frame is comparably limi
101  Union (EU) and another is being advanced to licensure in the U.S. and U.K. Despite the clear-cut ben
102                                        Since licensure in the United States, studies have shown that
103 AGE) during the first 10 years since vaccine licensure, including recent evidence from countries with
104 important policy concerns about professional licensure, including why, under current patient-centered
105 nd regulatory assessment, with a goal toward licensure is critical for these products.
106 tion of the safety profile of vaccines after licensure is crucial to accurately characterise safety b
107                                Essential for licensure is that the AIT product investigated remains c
108 petition by promoting the reestablishment of licensure laws in the late 1800s.
109                                              Licensure laws were almost nonexistent, and any citizen
110 Little is known about how state-level driver licensure laws, such as in-person renewal, vision tests,
111 tering the driver license system, includes 3 licensure levels, each with driving restrictions and req
112 verage and payment policy and concerns about licensure, liability, and other issues.
113 and fines, civil monetary penalties, loss of licensure, loss of staff privileges, and exclusion from
114          Recent advancements have led to the licensure of 3 RSV vaccines for older adults and pregnan
115                                        After licensure of a conjugate vaccine for invasive pneumococc
116 ntified on infant sera supports the case for licensure of a GBS polysaccharide-protein conjugate vacc
117 ntified on infant sera supports the case for licensure of a GBS polysaccharide-protein conjugate vacc
118                                              Licensure of a Group B streptococcus (GBS) polysaccharid
119                                              Licensure of a group B Streptococcus (GBS) polysaccharid
120                               To support the licensure of a new and safer vaccine to protect people a
121 sing threat of antimicrobial resistance, and licensure of a new generation of typhoid conjugate vacci
122 ying military personnel with development and licensure of an effective tetravalent dengue vaccine a p
123                     Key studies that lead to licensure of antiretroviral medications usually involve
124                                              Licensure of any medical countermeasure may require demo
125 apeutics are advancing, including the recent licensure of baloxavir; however, many remain to be evalu
126 ays to accelerate the regulatory pathways to licensure of combinations and other concrete, innovative
127                                     With the licensure of maternal respiratory syncytial virus (RSV)
128 c health responses, including production and licensure of new influenza A (H1N1) 2009 monovalent vacc
129 ata from these assays for the evaluation and licensure of new or adapted COVID-19 vaccines.
130 dictive of protection could facilitate rapid licensure of new vaccines.
131 ese models toward the goal of utility in the licensure of next-generation alphavirus vaccines and the
132 termeasures has provoked the development and licensure of novel COVID-19 vaccines in an unprecedented
133  reports to VAERS in the first 2 years after licensure of PCV described generally minor adverse event
134 gy of PPE by MLST in Utah children after the licensure of PCV-7.
135 mmonly present in the United States prior to licensure of PCV-7.
136 therapeutic ethics; training, education, and licensure of practitioners; equity and access; and appro
137 omote the highly accelerated development and licensure of safe and efficacious COVID-19 vaccines in E
138 ss from clinical development towards product licensure of several programs presents challenges to gen
139 ed pathologic classification system and drug licensure of several targeted therapies over the last de
140 assays have been used in the development and licensure of the ChAdOx1 nCoV-19 (AstraZeneca; Oxford Un
141                    At roughly the same time, licensure of the combined measles-mumps-rubella-varicell
142 ecipients has been further improved with the licensure of the efficacious and less toxic letermovir.
143            These results build on the recent licensure of the European gene therapy product Glybera f
144  dengue interventions, particularly with the licensure of the first dengue vaccine and promising deve
145 elop safe and effective vaccines resulted in licensure of the first live oral vaccine, tetravalent, r
146 been slower for humans but 2011 will see the licensure of the first viral-vectored vaccine for humans
147  Trial (publicly funded and initiated before licensure of the HPV vaccines), with the aim of assessin
148                                        Since licensure of the human papillomavirus (HPV) vaccine in 2
149                                     After US licensure of the Merck varicella vaccine for immunocompe
150 sible viral targets have been identified and licensure of the most advanced clinical compounds can be
151 ediatric pneumococcal empyema (PPE) prior to licensure of the pneumococcal conjugate vaccine (PCV-7)
152 sed on background rates assessed prior to US licensure of the RV5 (2001-2005).
153  pneumoniae have serotype 3 infections since licensure of the seven-valent pneumococcal conjugate vac
154 icity risk is routinely evaluated during the licensure of therapeutic proteins.
155                                          The licensure of therapeutic vaccines to reduce zoster indic
156 nes against group B streptococcus (GBS), the licensure of these vaccines may have to rely on studies
157               During the first year after US licensure of TIV-HD, no new serious safety concerns were
158 he sporadic nature of henipavirus outbreaks, licensure of vaccines and therapeutics for human use wil
159               However, while development and licensure of vaccines is a major breakthrough, it repres
160                                       Before licensure of varicella vaccine in 1995, varicella was a
161 siderations for the clinical development and licensure of Zika vaccine candidates including a discuss
162 serogroup B (4CMenB) vaccine was used before licensure on the basis of special consideration by the F
163 that also comply with state/federal laws for licensure or are certified as an ASC and/or are accredit
164 WHO) prequalified vaccines, registration and licensure pathways, participation in WHO-convened joint
165 ection study data in vaccine development and licensure pathways.
166 velopment to emergency use authorization and licensure, pharmacovigilance of vaccine safety and surve
167                         More stringent state licensure policies such as vision tests, road tests, and
168 bjectives-advocacy, regulatory oversight and licensure, policy and post-licensure evaluation, and pos
169  2018 using the terms; pre-registration, pre-licensure, "pre-registration", "pre licensure", trainee,
170 urrent US Food and Drug Administration (FDA) licensure process underestimates the potential benefits
171 uch trials may subtract many months from the licensure process, making efficacious vaccines available
172                                     The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) s
173 sk of intussusception in large trials before licensure, recent postlicensure data from international
174  poor vision among drivers, and adherence to licensure regulations.
175 versight (10 of 43 [23%]) or training and/or licensure requirements (15 of 43 [35%]).
176 icine components, confusing legal issues and licensure requirements, and poor reimbursement.
177 everal issues such as HIPAA, state and local licensure requirements, credentialing and privileging, s
178 ration process and to harmonize training and licensure requirements.
179 valence of vision disorders and adherence to licensure requirements.
180 onal education in palliative care as part of licensure requirements.
181 liative care training, certification, and/or licensure requirements; (iv) that public and private pay
182 ility to purchase, possess, register, obtain licensure, retain, and/or carry a firearm of any sort.
183                                  For vaccine licensure, short-term efficacy was inferred from serum b
184 n product availability due to differences in licensure status as well as prohibitively high costs.
185                       Pre-licensure and post-licensure studies have provided data supporting vaccine
186  Cohort studies, randomized trials, and post-licensure studies have reported reduced natural and vacc
187                                   While post-licensure studies have shown substantial declines in rot
188 t data may be used together with prospective licensure studies of BNT162b2 efficacy and safety and co
189 ta-analysis, we included observational, post-licensure studies of rotavirus vaccines, published from
190 e settings as anticipated from pre- and post-licensure studies.
191  younger, and biosimilar vaccines, with post-licensure surveillance confirming effectiveness.
192                                         Post-licensure surveillance is needed to monitor vaccine perf
193 certainty remains about how the professional licensure system regulates physician-spread misinformati
194  the development of a new vaccine through to licensure takes many years, this leaves Africa vulnerabl
195  used by students in preparation for medical licensure testing.
196 d during clinical trials and continued after licensure to fully evaluate the effect of RSV preventive
197 ll as for college or board certification and licensure to practice medicine.
198 ion, pre-licensure, "pre-registration", "pre licensure", trainee, student, students, nurs*, virtual-r
199 s who got 1 of the 2 HPV vaccines in phase 3 licensure trials, virtually all consented to registry-ba
200 ountermeasures against anthrax in support of licensure under the FDA's "Animal Rule." However, a need
201 ical development and the routine use in post-licensure vaccination campaigns existing regulatory requ
202                         The analysis of post-licensure vaccine adverse event report data also provide
203 d structural vaccinology (SV) and (iii) post-licensure vaccine success and adverse event surveillance
204                                              Licensure was based on immunogenicity data comparing PCV
205 h to U.S. Food and Drug Administration (FDA) licensure was tracked.
206 es and treatments against Nipah virus (NiV), licensure will likely require animal models, most import
207 lity of vaccines progressing from phase 2 to licensure within 10 years was 10.0% (95% CI, 2.6% to 16.
208 ines advancing from launch of phase 2 to FDA licensure within 10 years.
209 m phase 1 to 2, phase 2 to 3, and phase 3 to licensure within the total available follow-up time were
210             Surveillance studies in the post-licensure years have shown an increase in non-vaccine ty

 
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