ライフサイエンスコーパス: authorization

1 ries at co-payments of <or=$35 without prior authorization).

2 osteroids were identified (4 denied research authorization).

3 ting higher-altitude flights without federal authorization.

4 ew board, and patients consented to research authorization.

5 h Regulators, Predict and Prevent, and Prior Authorization.

6 r authorization and, if so, the criteria for authorization.

7 rigorous evaluation before obtaining market authorization.

8 cine occurred 10.0 years prior to regulatory authorization.

9 igible for mAb treatment under emergency use authorization.

10 to the U.S. FDA revoking their emergency use authorization.

11 ents of $0-$35 and 27% (4/15) required prior authorization.

12 through the Galapagos Marine Reserve without authorization.

13 ly modified pig hearts under expanded-access authorization.

14 ns in the evidence and controls required for authorization.

15 , WIC-eligible foods that DVS carried before authorization.

16 lts, and some products have already received authorization.

17 ral vaccines have now received emergency use authorization.

18 n of raw data from drugs for their marketing authorization.

19 nd processed meats) were not affected by WIC authorization.

20 Food and Drug Administration emergency use authorization.

21 . Food and Drug Administration Emergency Use Authorization.

22 ard-approved waiver of consent and waiver of authorization.

23 here would be no issues with insurance prior authorization.

24 w, with waiver of informed consent and HIPAA authorization.

25 he-counter (OTC) syringe sales pending local authorization.

26 fficacy data available at the time of market authorization.

27 thorized devices (predicates) to support new authorizations.

28 lonal antibodies have received emergency use authorization(1-3), and more treatments are under develo

29 notherapies that have received emergency use authorization(1-3).

30 , 12.9%-14.8%), and getting health plan care authorization (16.6%; 95% CI, 14.6%-18.6% vs 10.8%; 95%

31 p is distinguished by: (1) the lack of prior authorization; (2) a review of all prescribed anti-infec

32 ants), a study conducted under Emergency Use Authorization (210 participants), and 2 RCTs (with 80 an

33 Only ARNI required prior authorization (24.3% of plans), and step therapy was req

34 e DMG bundle at referral, 15% at the time of authorization, 33% at 12 to 18 hours, and 45% prior to r

35 n-differences regression to evaluate how WIC authorization affected sales of WIC-eligible foods in 8

36 Cost and prior authorization affected the therapy choices of uveitis sp

37 85 oncology therapies (95%) before European authorization and 4 therapies (5%) after.

38 gible participants with medical practitioner authorization and adherent to a 4-week run-in medication

39 sales revenue of $842 million during market authorization and annual sales had a steady decline from

40 l trials that led to the rapid emergency use authorization and approval of several COVID-19 vaccines

41 rly in device development to expedite market authorization and can accept greater uncertainty in bene

42 A waiver of authorization and patient consent was granted by the ins

43 ld contribute to an application to marketing authorization and plan accordingly.

44 Prior authorization and quantity limits were rarely applied, e

45 at such devices undergo before FDA marketing authorization and subsequent clinical deployment.

46 defining benchmarks to facilitate regulatory authorization and subsequent clinical setting generaliza

47 d between referrals that warranted immediate authorization and those that required further informatio

48 hether prescription of coxibs required prior authorization and, if so, the criteria for authorization

49 velopment and are refined prior to marketing authorization and, in some cases, after marketing.

50 S-CoV-2 vaccines have received emergency use authorization and/or licensure from the US Food and Drug

51 Authorizations and HTAs in selected countries.

52 s real-world data (RWD) to support marketing authorizations and satisfy postapproval study requiremen

53 attitudes toward financial incentives, donor authorization, and presumed consent and to identify mult

54 Financial incentives, donor authorization, and presumed consent are strategies desig

55 oncerns, and requirements, have the records, authorizations, and go-ahead of previously agreed requir

56 us teams, transparency, the record of client authorizations, and the go-ahead on previous development

57 oval date, review time, submission of market authorization application, accelerated approval or condi

58 amples when compared to an FDA Emergency Use Authorization approved assay, following published FDA gu

59 psid antibody by a commercial, emergency use authorization-approved antigen capture assay.

60 Patient experiences with prior authorization are largely unexplored, with most surveys

61 ation management strategies, including prior authorization, are commonly used to facilitate safe and

62 -19 vaccines and have received emergency use authorization as therapeutics.

63 studies once following conditional marketing authorization, as there will be even more treatment opti

64 Black patients provided authorization at a 31% lower rate than White patients (I

65 Health insurance companies may require prior authorization at any stage in the cancer care continuum,

66 reak response under an emergency use listing authorization based on supportive clinical trial data.

67 The authorization-based extension of Bittorrent and accompan

68 ctor that has received conditional marketing authorization, BB305, LVB-sha2 shows 1.7-fold greater po

69 ose of a COVID-19 vaccine with emergency use authorization (BNT162b2 [Pfizer-BioNTech], mRNA-1273 [Mo

70 5 FDA-approved drugs were refused marketing authorization by an international regulatory agency due

71 of which 162 (78.6%) were granted marketing authorization by at least 1 other regulatory agency at a

72 Marketing authorization by national authorities is necessary; howe

73 ular diagnostic assays granted emergency use authorization by the FDA using nasopharyngeal swabs from

74 accines that have been granted emergency use authorization by the U.S. Food and Drug Administration.

75 g therapy and has been granted Emergency Use Authorization by the US Food and Drug Administration for

76 , 324 of whom received and entered an upload authorization code.

77 For every 10.9 (95% SI, 7.6-15.6) upload authorization codes entered in the app, 1 contact had po

78 terior uveitis is affected by cost and prior authorization concerns, pregnancy considerations, and su

79 e basis for the first two EUA (Emergency Use Authorization) COVID-19 vaccines.

80 Prior authorization creates significant administrative burdens

81 e to receive mAbs according to emergency use authorization criteria.

82 Authorization data were easily accessible for the United

83 At the time of initial authorization, data beyond 2 months after vaccination we

84 Given recent RSV vaccine authorizations, data on groups at highest risk are neede

85 individuals from the earliest Emergency Use Authorization date for the BNT162b2 vaccination and was

86 Organ authorization decreased by 11% during the current pandem

87 studies with assays cleared by emergency use authorization demonstrate high specificity and sensitivi

88 European marketing authorization did not lead to automatic European access,

89 er 2006, excluding those who denied research authorization, did not have a baseline serum creatinine

90 to patients, an oversight committee, patient authorization, disclosure or prohibition of conflicts of

91 the Abbott SARS-CoV-2 RealTime emergency use authorization (EUA) (limit of detection [LoD], 100 copie

92 Veritor met FDA emergency use authorization (EUA) acceptance criteria for SARS-CoV-2 a

93 Assays that have Emergency Use Authorization (EUA) and are routinely used to detect Ebo

94 the Abbott RealTime SARS-CoV-2 Emergency Use Authorization (EUA) assay on the Abbott m2000 platform.

95 ic platforms have been granted emergency use authorization (EUA) by the Food and Drug Administration

96 n the United States has led to Emergency Use Authorization (EUA) facilitating the availability of mol

97 ug Administration (FDA) issued emergency use authorization (EUA) for convalescent plasma (CP) for the

98 Administration (FDA) issued an Emergency Use Authorization (EUA) for intravenous peramivir, an unappr

99 patients and recently received emergency use authorization (EUA) for treatment of COVID-19.

100 SARS-CoV-2 nucleic acids have emergency use authorization (EUA) from the FDA.

101 molecular tests have received emergency use authorization (EUA) from the Food and Drug Administratio

102 -CoV-2) have recently received emergency-use authorization (EUA) from the U.S. Food and Drug Administ

103 SARS-CoV-2 antibody tests with emergency use authorization (EUA) from the U.S. Food and Drug Administ

104 n (FDA), with the exception of Emergency Use Authorization (EUA) guidance for COVID-19 tests.

105 and Drug Administration (FDA) emergency use authorization (EUA) is required for clinical application

106 an adenoviral vector, received Emergency Use Authorization (EUA) on February 27, 2021.

107 and Drug Administration (FDA) Emergency Use Authorization (EUA) pathway.

108 ministration (FDA) has granted emergency use authorization (EUA) status to many SARS-CoV-2 serologic

109 to examine the agreement among emergency use authorization (EUA) tests for the detection of ZEBOV nuc

110 d Access Program (EAP) and the Emergency Use Authorization (EUA), leading to use in about 500,000 pat

111 in the United States under an Emergency Use Authorization (EUA).

112 dministration (FDA) has issued emergency use authorizations (EUAs) for monoclonal antibodies (mAbs) f

113 xpenses for initiation and maintenance of TA authorizations far exceed their related revenues and man

114 Thirty-two states required prior authorization for > or = 1 biologic DMARD, with wide var

115 g Administration has issued an emergency use authorization for 2 oral antivirals, molnupiravir (in pe

116 This study led to European clinical trial authorization for a phase II study in a homogeneous pati

117 S Food and Drug Administration (FDA) De Novo authorization for an autonomous AI for such use.

118 Prior authorization for any cancer-related service.

119 ion of Medicare Part D plans requiring prior authorization for buprenorphine products before and afte

120 al antibodies (mAbs) have received emergency authorization for coronavirus disease 2019 (COVID-19) tr

121 ated in this document: (a) simplification of authorization for diagnostic allergens; (b) specific reg

122 positories and the standards for a waiver of authorization for disclosure and use of such data.

123 gan procurement organization, at the time of authorization for donation, 12 to 18 hours later, and pr

124 veral COVID-19 vaccines have recently gained authorization for emergency use.

125 (vs 23% and 65% higher risk of approach and authorization for non-Black vs Black referrals).

126 United States marketing authorization for one drug, gefitinib (an epidermal grow

127 ilable tests have not received Emergency Use Authorization for performance with self-collected anteri

128 recently demonstrated that a policy of prior authorization for prescription of nonsteroidal anti-infl

129 re collected from patients with payer-denied authorization for radiation therapy (RT) from November 1

130 of the ambiguity surrounding deceased donor authorization for research, Health Insurance Portability

131 1, 1997, to December 31, 2002, who had given authorization for retrospective research were included.

132 FDA authorization for the commercial use of four cannabinoid

133 ications had been withdrawn or denied market authorization for the European Union by the EMA.

134 to determine whether to grant emergency use authorization for the test, which excluded a qRT-PCR ref

135 Molnupiravir was granted emergency use authorization for the treatment of mild to moderate coro

136 Paxlovid was granted an Emergency Use Authorization for the treatment of mild to moderate coro

137 States that implemented prior authorization for these agents initially had lower use o

138 . Food and Drug Administration Emergency Use Authorization for this agent.

139 and World Health Organization emergency use authorization for this EVD outbreak, in February 2015.

140 e discuss, among other topics, Emergency Use Authorizations for medical devices and privacy laws of t

141 consented to organ donation via first person authorization (FPA) registration before death become org

142 First-person authorization (FPA) was associated with threefold higher

143 September 2018 and June 2019 after receiving authorization from the ethics committee for health resea

144 The study received a waiver of authorization from the institutional review board, infor

145 hile 33 studies (46.5%) received a waiver of authorization from the respective ethical review boards.

146 (RT-PCR) assays have received Emergency Use Authorization from the U.S. Food and Drug Administration

147 BioNTech and Moderna) received emergency use authorization from the US Food and Drug Administration i

148 l trials and recently received Emergency Use Authorization from the US Food and Drug Administration(3

149 bility and immunogenicity, recently received authorization from the World Health Organization for use

150 0; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of

151 All the authorizations from the client generate push notificatio

152 the ones that were issued an "Emergency Use Authorization" from the U.S. Food and Drug Administratio

153 of Medicine in which consent was obtained or authorization given from the Orleans Parish Coroner's Of

154 ignificantly decreased from 15% in the prior-authorization group to 11% in the limited-use group (P=0

155 ity assessments led to European Union market authorization in 2020.

156 tored vaccine ChAd3-MARV under emergency use authorization in a phase 2 clinical trial.

157 be attributable to the elimination of prior authorization in California during the same time frame.

158 h (177)Lu-DOTATATE having acquired marketing authorization in Europe and the United States.

159 ccines are now available under emergency use authorization in the United States and have demonstrated

160 (Covid-19) that have received emergency use authorization in the United States are highly effective,

161 r and molnupiravir received an Emergency Use Authorization in the United States at the end of 2021.

162 irmatrelvir/ritonavir received emergency use authorization in the United States in 2021 and was appro

163 try, then prequalified and given a marketing authorization in the user countries.

164 Even with reduced payer-mandated prior authorization in these arrangements, payers and healthca

165 ncial conflicts of interest, lack of patient authorization, inappropriate access to information by th

166 icaid initiatives in 2019 that removed prior authorizations, increased reimbursement for office-based

167 Ten years after pediatric PCV7 authorization, IPD due to PCV7 serotypes had decreased b

168 ined commercial approval in Europe, and U.S. authorization is anticipated.

169 If WIC authorization is financially viable for small-format var

170 Of the three initiatives, donor authorization is likely supported by more donor and nond

171 ation SARS-CoV-2 Ag tests with Emergency Use Authorization is mostly limited to single, one-time test

172 Under the Emergency Use Authorization issued in April 2009, oseltamivir can be u

173 to be monitored as part of the emergency use authorizations issued for COVID-19 vaccines.

174 d HIV adherence issues, and 10 had insurance authorization issues.

175 regulatory requirements for continued market authorization, its efficacy and safety must be confirmed

176 rts and vision of the multistakeholder Prior Authorization Learning Collaborative of the Value in Hea

177 public regarding existing and proposed donor authorization legislation and its benefits for registere

178 times (compared with Medical Device User Fee Authorization [MDUFA] goals); (3) premarket pivotal stud

179 luding preferred drug/formulary lists, prior authorization, medication dosing/number limits, "fail-fi

180 Existing authorizations need to be kept in the market in some EU

181 Chronologically, authorization occurred ~10 years earlier in Europe (Unit

182 were also used as predicates to support the authorization of 265 descendant devices, with 50 index d

183 S Food and Drug Administration (FDA) de novo authorization of an example, the first autonomous point-

184 systems utilizing Cerner to facilitate prior authorization of antimicrobials, prospective audit and f

185 ehealth services among private insurers; (2) authorization of audio-only telehealth services for Medi

186 Our findings support the emergency use authorization of bebtelovimab for treatment of COVID-19

187 Many dossiers submitted for the authorization of chemicals have attempted to provide the

188 than 1 year in 2017, but total time from the authorization of clinical testing to approval has remain

189 atory harmonization, considering streamlined authorization of CV medical technologies across selected

190 valuates safety and effectiveness for market authorization of medical devices while CMS determines wh

191 ir resistance in the United States after the authorization of nirmatrelvir.

192 r, verification of mismatch recognition, and authorization of repair.

193 Authorization of severe acute respiratory syndrome coron

194 Drug Administration only gave emergency use authorization of the BNT162b2 and mRNA-1273 SARS-CoV-2 v

195 ulating interest in the field and leading to authorization of the first cadre of TCIs to be marketed.

196 Authorization of the Matrix-M (MM)-adjuvanted R21 vaccin

197 Following the emergency use authorization of the mRNA-1273 vaccine on the 18(th) of

198 ting these data was a condition of US market authorization of the WATCHMAN device.

199 rdens amplified the negative impact of prior authorization on patients.

200 efficacy data have led to the emergency use authorization or approval of COVID-19 vaccines in severa

201 regulators or NICE, and 12 drugs were denied authorization or coverage owing to insufficient safety,

202 s considered to have ADHD if they had (1) an authorization or filled prescription for stimulant treat

203 regularly prescribed outside their marketing authorization or through compassionate use programs.

204 be accessed for research purposes (ie, with authorization or waiver of authorization, when only a li

205 the security, confidentiality, authenticity, authorization, or integrity of medical data/images.

206 o (OR) 1.23 (95% CI 1.18, 1.27), approach to authorization: OR 1.64 (95% CI 1.56, 1.72), authorizatio

207 A Privacy Rule's requirements for individual authorization overlap substantially.

208 cantly more favorable attitudes toward donor authorization (P<0.0001) and presumed consent (P<0.0001)

209 nd private insurance providers require prior authorization (PA) for OPAT, yet impact of the inpatient

210 nd private insurance providers require prior authorization (PA) for OPAT, yet the impact of the inpat

211 visual outcomes, have been included in prior authorization (PA) initiatives.

212 Prior authorization (PA) is widely used by insurers to control

213 Prior authorization (PA) requirements for buprenorphine are as

214 Prior authorization (PA) requires clinicians and patients to n

215 en introduced primarily though Emergency Use Authorization pathways during the SARS-CoV-2 pandemic.

216 l infarction increased from 35% in the prior-authorization period to 88% in the limited-use period.

217 Drug Administration issued an Emergency Use Authorization permitting FFR decontamination and reuse.

218 vary widely in their implementation of prior authorization policies to limit use of biologic DMARDs.

219 proportions in states with and without prior authorization policies.

220 We obtained biologic DMARD prior authorization policy information from state Medicaid pro

221 Introduction of a new prior authorization policy on an established drug regimen is a

222 in a pharmacy-benefits program from a prior-authorization policy to a less restrictive, limited-use

223 tibiotic therapy (DOT) using preprescription authorization (PPA) vs postprescription review with feed

224 015, their high cost has led to strict prior authorization practices and high copays, and use of PSCK

225 rences in therapy choice based on cost/prior authorization, pregnancy, and subspecialty practice.

226 fore considering a revision of the marketing authorization process for antibacterial generic products

227 ation after circulatory death determination, authorization process, general contraindications to dona

228 of SARS-CoV-2 testing, and the emergency use authorization process.

229 d carding and electronic and automated prior authorization processes.

230 ot influenced by the degree to which a prior-authorization program incorporated evidence-based prescr

231 The removal of a prior-authorization program led to improvement in timely acces

232 terns after the implementation of each prior-authorization program.

233 Twenty-two states implemented prior-authorization programs for coxibs during the study perio

234 stantially after the implementation of prior-authorization programs.

235 ders without any special knowledge of access/authorization protocols.

236 sic immunological research and for marketing authorization purposes by regulatory authorities.

237 ilization management requirements (eg, prior authorization, quantity limit requirements) for acampros

238 Plans' prior authorization, quantity limit, and step therapy policies

239 errals (350 for each specialty) showed a 32% authorization rate according to the reference standard.

240 Correlation between an individual OPO's authorization rate among approached families, and overal

241 donation, was negative, suggesting that high authorization rates may be the result of selective appro

242 rs and having previous experience with prior authorization, recruited from social media, email lists,

243 edical records were reviewed to assess prior authorization requests, appeals, and related data for in

244 Prior authorization requirements are increasing but little is

245 ate Medicaid programs have implemented prior-authorization requirements before coxibs can be prescrib

246 study site was granted exemption from prior authorization requirements by radiology benefits manager

247 There were 18 states with prior authorization requirements for adalimumab or etanercept.

248 ort from industry and concern about flexible authorization requirements reflect the tension between e

249 minimal additional text to also satisfy the authorization requirements under the HIPAA Privacy Rule.

250 Coverage status, authorization requirements, service limitations, and cli

251 ar to that in states that did not have prior authorization requirements.

252 rventional procedures, although with varying authorization requirements.

253 Although reimagining prior authorization requires collective action by all stakehol

254 me EU states, while others need complete new authorizations requiring clinical trials, quality assura

255 anic referrals had 46% and 35% lower odds of authorization, respectively (all p < .001).

256 ant infections, in which Special Medical Use authorization restricted to patients with limited option

257 s Food and Drug Administration Emergency Use Authorization rule has been in effect since the early 20

258 Post-authorization safety data have also identified myocardit

259 ted by a Node.js Genboree authentication and authorization service (GbAuth), a graph database called

260 fectiveness of drug products after marketing authorization showing how RCT results are transferred in

261 c antioxidant from rosemary with a marketing authorization, spontaneously forms a relatively stable i

262 ccelerated approval or conditional marketing authorization status and proportion of approvals prior t

263 deductibles, lower premiums, and fewer prior authorization, step therapy, and quantity limit restrict

264 gn and administer increasingly complex prior authorization systems to balance value and appropriate u

265 the Abbott RealTime SARS-CoV-2 Emergency Use Authorization test.

266 In case of new authorizations, the events can easily be added to the ex

267 ime, money, and resources required for prior authorizations, the frequent rejections, and the percept

268 y analysis of patient experiences with prior authorization, themes centered on how, from the patient

269 Web protocols for secure authentication and authorization, these protocols are not in wide use in bi

270 panded as more pediatric age groups received authorization through May and June 2022.

271 Prevention to use the Emergency Utilization Authorization to allow clinical and commercial laborator

272 for which CAR-Ts have been granted marketing authorization to date.

273 Brain-dead donors are moved within hours of authorization to fully equipped intensive care units.

274 authorization: OR 1.64 (95% CI 1.56, 1.72), authorization to procurement: OR 1.08 (95% CI 1.02, 1.14

275 istry of Health granted fast-track marketing authorization to RNA polymerase inhibitor AVIFAVIR (favi

276 NmAb) treatments have received Emergency Use Authorization to treat patients with mild or moderate CO

277 (DF) has received European Medicines Agency authorization to treat sinusoidal obstruction syndrome,

278 h as documentation status, potential lack of authorization to work in the United States, and language

279 d about 50% of hired farmworkers do not have authorization to work in the United States.

280 ducts have already been used under emergency authorizations to treat patients in Africa as well as pa

281 and 45 restrictions and 544 applications for authorization under the REACH regulation, this study aim

282 on how, from the patient perspective, prior authorization was a confusing process that added to the

283 Excluding cases where donation authorization was based on prior patient documentation (

284 A waiver of authorization was granted by the institutional review bo

285 nrollment was terminated after emergency use authorization was granted for convalescent plasma.

286 On August 9, 2022, an emergency use authorization was issued for intradermal administration

287 rature protocols, which were initiated after authorization was obtained for the organ to be donated a

288 oard and written informed consent with HIPAA authorization was obtained.

289 Obtaining prior authorization was the duty shared among PHOs, nurses, an

290 mmercial-scale CCS demonstration project and authorization was viewed as more similar to that for a p

291 Conducted under an investigational new drug authorization, we prospectively enrolled patients with n

292 Conducted under an investigational new drug authorization, we prospectively enrolled patients with n

293 ology Project facility and provided research authorization were eligible for the study.

294 herapy for each vignette when cost and prior authorization were equalized (P = .0018, P = .0049, and

295 Patients without research authorization were excluded.

296 64, and that the criteria for waived patient authorization were met.

297 urposes (ie, with authorization or waiver of authorization, when only a limited data set is evaluated

298 nstitutional review board issued a waiver of authorization, which included a waiver of informed conse

299 70 (86.4%) remained eligible after physician authorization, with 1237 randomized to the intervention

300 cases (1.9%) ultimately did not receive any authorization, with 3 (1.5%) not undergoing RT, and 1 (0