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1 udents at each school who received a medical exemption).
2 l care (e.g., ambulance network and user-fee exemptions).
3 The study received internal review board exemption.
4 eral legislation under an explicit antitrust exemption.
5 d Drug Administration investigational device exemption.
6 d clinical trial with investigational device exemption.
7 have undermined the purpose of the medicine exemption.
8 price negotiation because of the sole orphan exemption.
9 study or on the basis of a compassionate use exemption.
10 requirements for obtaining a personal belief exemption.
11 ease risk in the context of vaccine delay or exemption.
12 Here we identify an exemption.
13 4, among states that offered personal belief exemptions.
14 should know the regulatory criteria for the exemptions.
15 offset by the larger reduction in nonmedical exemptions.
16 determine the reasons why individuals claim exemptions.
17 ublic health on overall vaccine coverage and exemptions.
18 ket notification, and investigational device exemptions.
19 replaced by increases in medical vaccination exemptions.
20 minating school-entry nonmedical vaccination exemptions.
21 , Senate bill 277 eliminated personal belief exemptions.
22 e study had high rates of nonmedical vaccine exemptions.
23 proportions with medical or personal-belief exemptions.
24 MR vaccine, with 2.5% having personal-belief exemptions.
25 -0.41% of enrolled children received medical exemptions.
26 main unvaccinated because of personal belief exemptions.
27 mean annual decreases in medical vaccination exemptions (0.02%; 95% CI, 0.01%-0.03%) through the end
29 ibrillator IDE study (Investigational Device Exemption), a successful conversion test required 2 cons
31 1, 2008, as cutoff points, when delivery-fee exemption and free health insurance were introduced in G
35 y reports, hospital discharges and copayment exemptions and matched with up to five references by sex
36 al-use concept may inform decision-making on exemptions and provide insights on its implementation.
38 S and product data, inappropriately designed exemptions and thresholds, and limited agency resources
39 at geographic clusters of nonmedical vaccine exemptions and waning immunity may have been factors con
40 to understand the role of nonmedical vaccine exemptions and waning immunity may have had on the resur
41 ne, 1 (2%) was unvaccinated due to religious exemption, and 1 (2%) had unknown vaccination status.
42 s, and rubella (MMR) vaccination, nonmedical exemption, and medical exemption in children entering ki
43 ates than states that offered only religious exemptions, and states that easily granted exemptions ha
44 law, ie, a mandatory vaccination law without exemptions, applies equally to everyone, but its effects
45 rsonal belief exemptions and easily granting exemptions are associated with higher and increasing non
46 lief exemptions and states that easily grant exemptions are associated with increased pertussis incid
50 tion before policies to eliminate nonmedical exemptions are implemented widely and outline a process
53 health care use of adults applying for such exemptions at a Yale New Haven Hospital care practice be
54 through 2004 state-level rates of nonmedical exemptions at school entry and 1986 through 2004 pertuss
56 zed Model for End-stage Liver Disease (MELD) exemption because of inadequate evidence suggesting mort
59 that government policies removing nonmedical exemptions can be effective at increasing vaccination co
61 We included 515 IDE (Investigational Device Exemption) clinical trial patients and 500 Continued Acc
63 s in Michigan and geographic overlap between exemptions clusters and clusters of reported pertussis c
66 iagnostic, surgical procedure and co-payment exemption codes, pharmacy claims and specialist's visits
70 Approvals, De Novo, and Humanitarian Device Exemption databases from January 2019 to December 2021 f
71 ed in the placebo tests, top 5%), nonmedical exemptions decreased by 2.4% (top 2 of 43 states evaluat
72 erval [CI] 2.9%-5.8%, p < 0.001), nonmedical exemptions decreased by 3.9% (95% CI 2.4%-5.4%, p < 0.00
73 ible and 405 (70.6%) of these had nonmedical exemptions (eg, exemptions for religious or philosophica
74 kinson disease and has a humanitarian device exemption for dystonia and obsessive-compulsive disorder
76 The institutional review board granted an exemption for this HIPAA-compliant study; patient inform
78 islation around nonmedical (personal-belief) exemptions for childhood vaccination and possibly a spec
79 that legislative action to limit nonmedical exemptions for compulsory vaccination for school entry i
80 sed on Canadians who were granted Section 56 exemptions for legal psilocybin-assisted psychotherapy.
83 Specifically, the SECURE rule 1) establishes exemptions for plants modified by genetic engineering wh
84 .6%) of these had nonmedical exemptions (eg, exemptions for religious or philosophical reasons, as op
89 therefore be considered negligible, but the exemption from labelling should be allowed only when the
90 th study period, each study site was granted exemption from prior authorization requirements by radio
92 in nursing homes and individuals who had an exemption from the Danish mandatory governmental electro
95 ogy reports, hospital discharge records, and exemptions from prescription charges for clinical tests.
101 tory Authority to describe trends in medical exemptions from utility disconnection and characteristic
102 s exemptions, and states that easily granted exemptions had higher nonmedical exemption rates in 2002
103 2004, states that permitted personal belief exemptions had higher nonmedical exemption rates than st
104 he relationship with ease of obtaining these exemptions has not previously been examined in detail.
105 Worth, and Houston-are potential vaccination exemption "hotspots," with over 13% of local school syst
106 Humanitarian Use Device/Humanitarian Device Exemption (HUD/HDE) pathway in the development of new ca
107 ndage Occluder [LAAO] Investigational Device Exemption [IDE] Trial [Amulet IDE trial]; NCT02879448).
108 ndage Occluder [LAAO] Investigational Device Exemption [IDE] Trial) evaluated the safety and effectiv
111 y significant clusters of nonmedical vaccine exemptions in kindergarteners and 11 statistically signi
112 s evaluated spatial clustering of nonmedical exemptions in Michigan and geographic overlap between ex
113 rize the spatiotemporal landscape of vaccine exemptions in Michigan for the period 2008-2018 using Mo
114 10-2.14) and availability of personal belief exemptions (incidence rate ratio = 1.48; 95% confidence
115 justing for demographics, easier granting of exemptions (incidence rate ratio = 1.53; 95% confidence
116 d in the placebo tests, top 5%), and medical exemptions increased by 0.4% (top 1 of 44 states evaluat
117 % (95% CI 2.4%-5.4%, p < 0.001), and medical exemptions increased by 2.4% (95% CI 2.0%-2.9%, p < 0.00
118 accinating all children with personal-belief exemptions, increasing uptake by 10% to 50% in all low-i
120 these drugs, however, suggests that special exemption is unnecessary for them to achieve financial s
122 e LEADLESS II phase 1 investigational device exemption, LEADLESS Observational, or LEADLESS Japan tri
123 the first state to pass physician antitrust exemption legislation allowing physicians, under certain
125 eligious or personal beliefs (ie, nonmedical exemptions) may be a useful strategy to increase immuniz
126 19 amidst rising rates of nonmedical vaccine exemptions (NMEs) and low vaccination coverage compared
128 ystem should be rationalized not in terms of exemption of disease but in terms of change of reactivit
130 onal review board approval was received with exemption of informed consent for this retrospective HIP
134 , version 9.4, to analyze nonmedical vaccine exemptions of children entering kindergarten in 2011 and
135 contributions from donors, savings from tax exemptions on issued bonds, and federal unemployment tax
136 gislation eliminating nonmedical vaccination exemption options from school-entry requirements, the im
137 s seen in states that offered only religious exemptions or that had medium and difficult exemption pr
139 1020 patients in the investigational device exemption per-protocol population, 536 were still receiv
146 to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized
148 ically significant census tract clusters for exemption rates and 6 significant census tract clusters
149 ily granted exemptions had higher nonmedical exemption rates in 2002 through 2003 compared with state
151 onal belief exemptions had higher nonmedical exemption rates than states that offered only religious
152 h easier medical exemption criteria, medical exemption rates were significantly higher (adjusted inci
155 (i.e., hospital discharge records, copayment exemptions registry, pharmacy claims and specialist visi
157 mplementation, in addition to a reduction in exemption requests and healthcare-associated influenza.
158 ry care children's hospital, reducing annual exemption requests with a small number of terminations s
160 pective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with s
161 med consent, and an Investigational New Drug Exemption, six healthy volunteers and 10 patients with s
162 The study received internal review board exemption status, without the need for informed patient
163 , physician-sponsored investigational device exemption studies between 2005 and 2020 who underwent el
165 , multicenter pivotal investigational device exemption study of PerAF patients undergoing PVI+PWA wit
167 ministration-approved investigational device exemption study to evaluate feasibility and safety of TA
168 The SUPERB Trial, an investigational device exemption study using an interwoven nitinol wire stent i
169 d Drug Administration investigational device exemption study, evaluated the long-term safety and effe
170 d Drug Administration Investigational Device Exemption study, we used a novel system for real-time, h
172 d tissue regulations, including the hospital exemption system in the European Advanced Therapy Medici
175 ress could consider removing the sole orphan exemption to obtain additional savings for patients and
176 se initiatives include a process for federal exemptions to allow for pharmacologic treatment in offic
177 ssage of SB 277, which eliminated nonmedical exemptions to childhood immunizations for school entry.
178 hat eliminate nonmedical ("personal belief") exemptions to childhood vaccination requirements are con
180 ated counts and rates of state-level medical exemptions to kindergarten entry requirements over 7 sch
181 n more than 30 years to eliminate nonmedical exemptions to mandatory childhood immunizations for scho
184 cy on vaccination coverage and prevalence of exemptions to vaccine requirements (nonmedical and medic
186 ortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk pa
187 comes from the Melody Investigational Device Exemption trial affirm the benefits of Melody TPV replac
190 med as part of an FDA investigational device exemption trial protocol, and a national noncoverage dec
191 ticenter, single-arm, investigational device exemption trial to establish the safety and effectivenes
196 ments for all required vaccines) and medical exemption uptake (defined as the percentage of students
197 ean absolute decrease in medical vaccination exemption uptake at both public and nonpublic schools, a
206 n of kindergarteners with nonmedical vaccine exemptions was 2.8 times larger in the identified exempt
207 that eliminated nonmedical childhood vaccine exemptions was associated with an estimated increase in
208 epeal of school-entry nonmedical vaccination exemptions was associated with increased vaccine coverag
210 Vaccinating children with personal-belief exemptions was one of the most effective interventions t
211 nating the 972 children with personal-belief exemptions was similar to that of targeting all low-immu
212 Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter st
213 Institutional review board evaluation and exemption were granted for the study, as primary data we
218 ne hesitancy (nonmedical and personal belief exemptions), will have substantial public health and eco
219 eive the vaccine without documentation of an exemption, with 9 (0.06%) subsequently being terminated.