ライフサイエンスコーパス: approval

1 clinical trials of drugs granted accelerated approval.

2 acy and safety and achieve timely regulatory approval.

3 e same time frame, but failed to receive FDA approval.

4 y was exempt from institutional review board approval.

5 anomedicine development and their regulatory approval.

6 Panel-track supplement approval.

7 his study had institutional ethics committee approval.

8 re evaluated with institutional review board approval.

9 Granting of accelerated approval.

10 improve the economy and success rate of drug approval.

11 lting in its US Food and Drug Administration approval.

12 ses performed in the United States since FDA approval.

13 eloped and made available through regulatory approval.

14 a trial is intended to seek support for drug approval.

15 rol-lowering agents have received regulatory approval.

16 eived for all 41 drugs that ODAC recommended approval.

17 ioequivalence, the cornerstone of regulatory approval.

18 uld be regulated first and require premarket approval.

19 porated within a regulatory pathway for drug approval.

20 ly improved overall survival, leading to FDA approval.

21 s completed after institutional review board approval.

22 erating drug development, and for regulatory approval.

23 al on the first day, and 47.2% ever received approval.

24 ncology drugs through clinical trials to FDA approval.

25 ntrast agents to facilitate swift regulatory approval.

26 preferably with Food and Drug Administration approval.

27 very few vaccine-adjuvants have received FDA approval.

28 counteract its effects has reached clinical approval.

29 be warranted before T2 MELD exception point approval.

30 gs, comprising more than half of all new FDA approvals.

31 d is exempt from Human Subjects Review Board approval (11-DRDS-NR03).

32 did not differ before and after accelerated approval (12/30 [40%] vs 10/18 [56%]; difference, 16%; 9

33 For two thirds of approvals (24/35, 69%), all clinical studies were restri

34 ite the pathway from discovery to regulatory approval, a workshop with key stakeholders was held in S

35 le analyses examined factors associated with approval/abandonment including payor, prescriber special

36 stapproval trials a minimum of 3 years after approval, although confirmatory trials and preapproval t

37 tion from preclinical validation to clinical approval and adoption.

38 he study received institutional review board approval and all patients gave written informed consent.

39 as surrogate measures for drug targeting and approval and are generally based on plausible biological

40 eligible for pooling given adequate ethical approval and availability of essential variables.

41 ts awarded upon Food and Drug Administration approval and by patents.

42 h efforts during the past decade have led to approval and commercialization of several microneedle ba

43 The Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet

44 sions and estimated time between accelerated approval and fulfillment of regulatory requirements were

45 ve study received institutional review board approval and fully complied with HIPAA regulations for p

46 and Methods With institutional review board approval and Health Insurance Portability and Accountabi

47 Ethics approval and informed consent were obtained.

48 Materials and Methods Ethics approval and informed consent were obtained.

49 s and Methods Institutional ethics committee approval and informed consent were obtained.

50 rials and Methods Institutional review board approval and informed consent were obtained.

51 Methods Following institutional review board approval and informed consent, 26 subjects (16 men, 10 w

52 After institutional review board approval and informed consent, consecutive LT recipients

53 Materials and Methods After ethical approval and patient informed consent were obtained, two

54 nical care) should be sufficient for initial approval and reimbursement.

55 oster agreement on the evidence required for approval and reimbursement; improve transparency, accoun

56 Factors associated with approval and rejection of these medications in the Unite

57 We aimed to identify payer approval and rejection rates for PCSK9i prescriptions an

58 This study had institutional research board approval and was HIPAA compliant.

59 ds This study had institutional review board approval and was HIPAA compliant.

60 rials and Methods Institutional review board approval and written informed consent from all participa

61 2006 and 2016 with research ethics committee approval and written informed consent from each subject,

62 rials and Methods Institutional review board approval and written informed consent were obtained for

63 rials and Methods Institutional review board approval and written informed consent were obtained from

64 rials and Methods Institutional review board approval and written informed consent were obtained.

65 onal review board and local ethics committee approval and written informed consent were obtained.

66 A compliant, with institutional review board approval and written informed consent.

67 rials and Methods Institutional review board approval and written informed patient consent were obtai

68 tion was statistically significant for three approvals and missing for two.

69 atabase to identify and characterize initial approvals and subsequent postmarket modifications to Cla

70 mpliant study had institutional review board approval, and all participants gave written informed con

71 ds This study had institutional review board approval, and informed consent was obtained from 72 pati

72 alf of patients prescribed a PCSK9i received approval, and one-third of approved prescriptions were n

73 is study received institutional review board approval, and patients gave informed consent.

74 he study received institutional review board approval, and patients in the CLQ cohort provided inform

75 val, orphan status, near-regulatory deadline approval, and regulatory review time.

76 mpliant study had institutional review board approval, and the need for informed consent was waived.

77 rmination of safety and efficacy, regulatory approval, and vaccination delivery.

78 inally, some important barriers to marketing approval are described.

79 in three disease indications, and additional approvals are expected to broaden the clinical scope of

80 of potential for self-enhancement or social approval) are integrated into a domain-general value sig

81 od and Drug Administration (FDA) accelerated approval based on showing an effect in surrogate measure

82 he preapproval trials leading to accelerated approval between 2009 and 2013.

83 The ASCO guideline approval body, the Clinical Practice Guidelines Committe

84 inflation-adjusted monthly costs rose since approval by 49% and 44%, respectively.

85 the drugs' high cost, rates of prescription approval by payers may be low.

86 rugs with 24 indications granted accelerated approval by the FDA in 2009-2013, efficacy was often con

87 ity of studies and data evaluated to support approval by the FDA of modifications of high-risk device

88 After approval by the institutional review board, 1,022 LNs in

89 (68)Ga-DOTATATE approval by the U.S. Food and Drug Administration has tr

90 ia (ALL) eventually resulting in conditional approval by the U.S. Food and Drug Administration in 201

91 emaglutide-the latter being under review for approval by the US Food and Drug Administration and the

92 Randomized clinical trials of oncology drug approvals by the US Food and Drug Administration, Europe

93 The probability of regulatory approval can conceivably be further enhanced by exploiti

94 Under the single-agent and KRd approvals, carfilzomib is administered as a 10-minute IV

95 Duty Test Cycle (WLTC) for Europe, and world approval cycles.

96 After ethics approval, data were collected from 1799 consecutive live

97 review, focusing on brand and generic name; approval date; applicant; indication; PRO labeling descr

98 from either September or December 2014 (the approval dates of the study drugs by the US Food and Dru

99 itoring of regulatory agencies for new drugs approvals ensures the resource is up-to-date.

100 ienced operators, in the real-world post-FDA approval experience of LAAC, procedural success was high

101 t between ODAC recommendations and final FDA approval; FDA approval was received for all 41 drugs tha

102 ed US Food and Drug Administration marketing approval for acute myeloid leukemia (AML) treatment: tar

103 This is the first drug to receive regulatory approval for AML in the United States since the year 200

104 Forty-seven participants gave approval for analysis of both oral fluid collection and

105 Approval for expanded access and compassionate use was r

106 ollowing the US Food and Drug Administration approval for laparoscopic gastric band surgery in 2001,

107 Rates of approval for PCSK9i therapy are low, even for patients w

108 Materials and Methods Ethical approval for the study was obtained from the ethical rev

109 venetoclax (Venclexta) recently received FDA approval for the treatment of a specific subset of patie

110 cently received Food and Drug Administration approval for the treatment of advanced melanoma, renal c

111 antibody targeting CTLA-4 that received FDA approval for the treatment of metastatic melanoma in 201

112 However, tDCS devices do not have regulatory approval for treating medical disorders, evidence is lar

113 e received U.S. Food and Drug Administration approval for treatment of advanced RCC in a little over

114 anti-inflammatory drugs that have regulatory approval for treatment of relapsing-remitting multiple s

115 Despite approval for treatment of various cancers, clinical appl

116 tes or currently in the process of obtaining approval for use in the United States.

117 ) in OPV-using countries required regulatory approval for use of inactivated poliovirus vaccine and b

118 Materials and Methods All authors received approval for use of NLST data.

119 ently, there are no guidelines or regulatory approvals for genomic somatic tumor mutation testing to

120 s and led to US Food and Drug Administration approvals for patients with a variety of malignant neopl

121 option with US Food and Drug Administration approvals for various tumor types.

122 cal studies before their marketing or formal approval from regulatory agencies, and for this reason t

123 After approval from the Human Research Ethics Committee was ob

124 als and Methods The study was performed with approval from the institutional animal care and use comm

125 Materials and Methods After approval from the institutional animal care and use comm

126 en March and September 2014, after receiving approval from the institutional animal care committee, 6

127 all-cell lung cancer (NSCLC) therapy, with 2 approvals from the US Food and Drug Administration of PD

128 Since its approval in 2006, the science of discovering and develop

129 Since its approval in 2011, the Janus kinase 1/2 (JAK1/2) inhibito

130 ic cancer type if it had received regulatory approval in any country for treatment of advanced cancer

131 national clinical registry since regulatory approval in March 2015, we obtained procedural data on i

132 ite the lack of Food and Drug Administration approval in the 3- to 4.5-hour time window.

133 irst and only retinal implant to have market approval in the European Economic Area, the United State

134 inoma and it has received accelerated US FDA approval in this setting on this basis.

135 Variables that were associated with PCSK9i approval included age >65 years (P<0.01), history of ath

136 Other factors associated with drug approval included having government vs commercial insura

137 tic characteristics known at the time of FDA approval, including drug class, therapeutic area, priori

138 criteria for transcatheter heart valve (THV) approval, including randomized, clinical trials.

139 02), and those with near-regulatory deadline approval (IRR = 1.90; 95% CI, 1.19-3.05; P = .008); even

140 8.06; P < .001), those receiving accelerated approval (IRR = 2.20; 95% CI, 1.15-4.21; P = .02), and t

141 tastases, whereas institutional review board approval is required before glass microspheres can be us

142 HER2-targeting agents have gained regulatory approval: lapatinib, pertuzumab, and trastuzumab-emtansi

143 ical evidence that supported an original FDA approval less relevant to newer device models.

144 However, only a few months after its approval, natalizumab was withdrawn from the market beca

145 supplemental US Food and Drug Administration approvals, new off-label indications, and new competitor

146 ttee of the University of Heidelberg (ethics approval number, S-320/2012), and informed consent was w

147 cordance with the institutional review board approval obtained at the two participating institutions,

148 Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-tr

149 A caveat is that an accelerated approval of a particular new drug using an intermediate

150 on of androgens, has been exemplified by the approval of abiraterone for the treatment of castration-

151 The approval of anti-programmed death ligand 1 (PD-L1) and a

152 tute the major criteria governing regulatory approval of any new drug.

153 of the disease are essential for regulatory approval of any treatment.

154 tion frequency is an important criterion for approval of asthma therapies, but the clinical features

155 The approval of bedaquiline to treat tuberculosis has valida

156 l-defined regulatory framework governing the approval of chemicals for use as pharmaceuticals or rele

157 After the approval of cisplatin as a chemotherapeutic agent in 197

158 Nurse-reported anger predicted approval of coercive violence management interventions;

159 nism-specific clinical trials and ultimately approval of critically needed new antibacterial agents.

160 With the approval of direct-acting antivirals (DAAs), the managem

161 rug Administration to support the regulatory approval of elbasvir and grazoprevir.

162 The approval of fondaparinux, a heparin-derived factor Xa (f

163 Recent approval of HCV direct-acting antivirals (DAAs) has rene

164 Among clinical studies used to support FDA approval of high-risk medical device modifications, fewe

165 Despite Food and Drug Administration (FDA) approval of hydroxyurea to reduce the frequency of vaso-

166 Here we summarize the precedent for FDA approval of imaging agents using effectiveness data from

167 a variety of cancers has coincided with the approval of IMLYGIC for metastatic melanoma.

168 The recent Food and Drug Administration approval of immunogenic oncolytic virus (OV) has opened

169 erscore the need to accelerate the study and approval of integrase inhibitors for use in young childr

170 s methods for FDA-directed human testing and approval of investigational optical imaging devices as w

171 platforms for early cancer diagnosis and the approval of methylation inhibitors for anticancer therap

172 atitis C virus (HCV) therapy have led to the approval of multiple oral direct-acting antiviral (DAA)

173 successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppr

174 roval of new treatments can be linked to the approval of new diagnostic assays used to measure effica

175 al and immune modulatory therapies such that approval of new treatments can be linked to the approval

176 s recommended that formal OPC be applied for approval of new-generation THVs for use in high- and ext

177 in oncology trials, resulting in regulatory approval of one isoform-selective inhibitor (idelalisib)

178 a (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA suppl

179 ter the ALSYMPCA study and before regulatory approval of radium-223.

180 In the decades since the approval of riluzole, the only US Food and Drug Administ

181 Following approval of rivaroxaban for the pulmonary embolism indic

182 s has accelerated, leading to the recent FDA approval of several drugs that reduce cancer progression

183 The last decade has seen the approval of several new biologics for the treatment of s

184 The approval of sofosbuvir, a nucleoside monophosphate prodr

185 Center, developed procedures for review and approval of strain requests, guidance during the selecti

186 inst T2DM has been invigorated by recent FDA approval of Symlin, which is a large conformationally re

187 the initial US Food and Drug Administration approval of that agent from 2011 to 2015; and a review o

188 It took 22 years after the FDA approval of the anti-excitotoxic drug Riluzole before an

189 VEGF, in 1989 paved the way for the clinical approval of the first antiangiogenic tumor drug 15 years

190 tegies culminating, in December 2016, in the approval of the first precise molecularly targeted thera

191 Methods All experiments were performed with approval of the institutional animal care and use commit

192 years) after obtaining written consent under approval of the institutional review board.

193 wo-step process that would include first the approval of the new drug by the regulatory agencies and

194 lthy control subject were recruited with the approval of the Newcastle and North Tyneside 2 ethics co

195 humans, with US Food and Drug Administration approval of the oncolytic herpesvirus talimogene laherpa

196 These studies supported the approval of the pediatric indication (use in children ag

197 proval requirements and the expectations for approval of these novel drugs and devices, packaged sepa

198 isks are identified after initial regulatory approval of these therapeutics.

199 Despite the recent approval of third-generation therapies, overcoming resis

200 tinct indications and is intended to support approval of this agent by the U.S. Food and Drug Adminis

201 Approval of this drug was based on progression-free surv

202 With the approval of transcatheter aortic valve replacement (TAVR

203 Since the approval of trastuzumab, a humanized monoclonal antibody

204 Despite this, regulatory approvals of all NOACs have been based on stroke prevent

205 For two thirds of FDA approvals of anticancer agents, the requirement for pred

206 The recent US Food and Drug Administration approvals of novel targeted therapies such as inhibitors

207 anomaterials, including the relative rate of approvals of these products, and provides a comprehensiv

208 gn and labeling changes, since their initial approvals, often without supporting clinical data.

209 The FDA granted nivolumab traditional approval on March 4, 2015, for treatment of metastatic S

210 atients given a prescription, 20.8% received approval on the first day, and 47.2% ever received appro

211 al therapeutics have yet received regulatory approval or demonstrated clinical efficacy.

212 The main outcome was approval or rejection of PCSK9i prescription claims.

213 erapeutic area, priority review, accelerated approval, orphan status, near-regulatory deadline approv

214 ringing new targeted radiopharmaceuticals to approval over the next few years.

215 setting list prices are issues of regulatory approval, patents and intellectual property, assessment

216 ient indications, and reassessing the safety approval pathway in light of 10 years worth of biosimila

217 cals and small-molecule drugs have different approval pathways but the same quality control (QC) para

218 characteristics increases the likelihood of approval, payer type is the most significant factor.

219 dence interval, 0.7-1.0) across their market approval period (P < 0.001).

220 ion (FDA) through various kinds of premarket approval (PMA) supplements.

221 Food and Drug Administration (FDA) Premarket Approval (PMA).

222 Although the generic drug approval process has a long-term successful track record

223 guided surgery, but the time and cost of the approval process may impede clinical translation.

224 ons have generated skepticism of the generic approval process.

225 y, which are important considerations in the approval process.

226 The development and approval processes of biosimilar mAbs depend on their co

227 ynthetic lethality and the route to clinical approval provide interesting lessons for the development

228 Commercial third-party payers had the lowest approval rates (24.4%) and Medicare had the highest (60.

229 disease were more likely to be approved, but approval rates did not vary by patient low-density lipop

230 Approval rates varied nearly 3-fold among the top 10 lar

231 terol levels were not associated with higher approval rates.

232 confirmed by confidential electronic voting; approval required that at least 80% of the panel members

233 Recommendation approval required the agreement of at least 80% of the t

234 The goal of this workshop was to discuss FDA approval requirements and the expectations for approval

235 SUBJECTS AND Following ethics board approval, second year residents were randomized to a tea

236 ug submission and institutional review board approval standards.

237 The regulatory approval status of the drugs for prophylaxis and for acu

238 number of patients with treatment failure in approval studies.

239 The PROMUS Element Plus Post-Approval study enrolled 2681 patients at 52 US sites wit

240 el pooling with the PROMUS Element Plus Post-Approval Study was prespecified.

241 These drugs corresponded to 35 approvals supported by 80 clinical studies included in t

242 ortem consent and institutional review board approval, the authors compared postmortem neuronal tissu

243 th at least one non-enriched trial, for five approvals, the non-enriched studies were non-randomized.

244 The FDA granted accelerated approval to 22 drugs for 24 indications (19 for indicati

245 The median time from approval to first postmarket safety event was 4.2 years

246 rsen and mipomersen, which have received FDA approval to treat cytomegalovirus retinitis and high blo

247 isease-modifying medications with regulatory approval to treat multiple sclerosis illustrates the sub

248 ts lacking U.S. Food and Drug Administration approval to treat ophthalmic disease, and AMD was the mo

249 4488 (before US Food and Drug Administration approval) to 429 of 5253 post-PSP injections (8.2%), a c

250 s) and a randomized controlled design by pre-approval trials and 2) the treatment-by-biomarker intera

251 catheter utilization after chest radiography approval was 2.4 hours.

252 Approval was based on an acceptable safety profile and h

253 ought input from ACPC Section members; final approval was by a vote of the ACPC Council.

254 rials and Methods Institutional review board approval was given and patient consent was not required

255 inical safety and performance after European approval was given.

256 essed; therefore, institutional review board approval was not sought.

257 ciation between ODAC recommendations and FDA approval was observed for members with FCOIs with the sp

258 rials and Methods Institutional review board approval was obtained and informed consent waived for th

259 rials and Methods Institutional review board approval was obtained and the requirement for informed c

260 Materials and Methods Local ethics committee approval was obtained at all sites for this prospective,

261 rials and Methods Institutional review board approval was obtained for active or passive consenting p

262 rials and Methods Institutional review board approval was obtained for this HIPAA-compliant study, wi

263 rials and Methods Institutional review board approval was obtained for this HIPAA-compliant, retrospe

264 rials and Methods Institutional review board approval was obtained for this prospective multi-institu

265 rials and Methods Institutional review board approval was obtained for this retrospective study.

266 Materials and Methods Ethical approval was obtained for this retrospective, HIPAA-comp

267 rials and Methods Institutional review board approval was obtained for this study; all patients gave

268 rials and Methods Institutional review board approval was obtained from Leipzig University.

269 Materials and Methods Ethics approval was obtained from the centralized institutional

270 After approval was obtained from the institutional animal care

271 Materials and Methods Approval was obtained from the local ethics committee.

272 rials and Methods Institutional review board approval was obtained with waiver of consent.

273 rials and Methods Institutional review board approval was obtained, and informed consent was waived i

274 rials and Methods Institutional review board approval was obtained, and patient consent was waived fo

275 rials and Methods Institutional review board approval was obtained, and the requirement to obtain inf

276 rials and Methods Institutional review board approval was obtained, with waiver of informed consent.

277 Materials and Methods Review board approval was obtained, with waiver of informed consent.

278 Institutional review board approval was obtained, with waiver of the need to obtain

279 med consent after institutional review board approval was obtained.

280 rials and Methods Institutional review board approval was obtained.

281 rials and Methods Institutional review board approval was obtained.

282 Institutional review board approval was obtained.

283 recommendations and final FDA approval; FDA approval was received for all 41 drugs that ODAC recomme

284 rials and Methods Institutional review board approval was waived, as the study used publicly availabl

285 rials and Methods Institutional review board approval was waived, as the study used publicly availabl

286 With institutional review board approval, we searched our prospectively acquired databas

287 tic characteristics known at the time of FDA approval were associated with increased risk.

288 with no reported FCOIs, recommendations for approval were made in 13 of 35 meetings (OR, 1.19; 95% C

289 Recommendations for approval were made in 28 of 47 meetings with members rep

290 d consent and institutional ethics committee approval were obtained.

291 and accelerated and near-regulatory deadline approval were statistically significantly associated wit

292 ore than one third (n = 64; 38%) of original approvals were intraocular lenses.

293 t the receptor tyrosine kinase FLT3, and its approval will hopefully mark the beginning of an era of

294 After institutional review board approval with a waiver of informed consent was obtained,

295 is study received institutional review board approval with waiver of consent.

296 Among the six approvals with a non-enriched randomized controlled tria

297 Among the 11 remaining approvals with at least one non-enriched trial, for five

298 ve study received institutional review board approval, with a waiver of the HIPAA requirement for inf

299 Methods Following institutional review board approval, with waiver of consent and with HIPAA complian

300 pective study had institutional review board approval; written informed consent was obtained from all