ライフサイエンスコーパス: Food and Drug Administration

1 n between users, manufacturers, and the U.S. Food and Drug Administration.

2 none has been validated for approval by the Food and Drug Administration.

3 fferent conditions, as recommended by the US Food and Drug Administration.

4 was recently approved by the United States' Food and Drug Administration.

5 SH-specific therapies are approved by the US Food and Drug Administration.

6 ment by the European Medicines Agency and US Food and Drug Administration.

7 rgency use authorization (EUA) from the U.S. Food and Drug Administration.

8 on of the ENDO trial (NCT01728116) by the US Food and Drug Administration.

9 fection without a therapy approved by the US Food and Drug Administration.

10 rea and L-glutamine - are approved by the US Food and Drug Administration.

11 r food allergies had been approved by the US Food and Drug Administration.

12 nted emergency use authorization by the U.S. Food and Drug Administration.

13 ed Emergency Use Authorization from the U.S. Food and Drug Administration.

14 77)Lu DOTATATE PRRT was approved by the U.S. Food and Drug Administration.

15 s (of which, 29 drugs are approved by the US Food and Drug Administration, 12 are in clinical trials

16 ived Emergency Use Authorization from the US Food and Drug Administration(3,4).

17 ptomic metric has been operationalized on an Food and Drug Administration 510(k)-cleared platform oth

18 homa(6) and were recently approved by the US Food and Drug Administration(7).

19 licy scenarios: (1) implementation of the US Food and Drug Administration added sugar labeling policy

20 Implementing the US Food and Drug Administration added sugar labeling policy

21 an Medicines Agency [EMA] EudraVigilance; US Food and Drug Administration Adverse Event Reporting Sys

22 adverse event reports form the United States Food and Drug Administration Adverse Event Reporting Sys

23 er twelve million reports from United States Food and Drug Administration Adverse Event Reporting Sys

24 pective cohort study was conducted using the Food and Drug Administration Adverse Event Reporting Sys

25 The Food and Drug Administration allows for using surrogate

26 The Food and Drug Administration Amendments Act (FDAAA) of 2

27 AR) T cells were recently approved by the US Food and Drug Administration and are poised to enter the

28 substitutes are already approved by the U.S. Food and Drug Administration and are readily available.

29 rted to the pharmacovigilance program of the Food and Drug Administration and associate signals to si

30 idly since simultaneous approval by the U.S. Food and Drug Administration and Centers for Medicare an

31 Food and Drug Administration and company websites were s

32 Nine ADCs have received approval from the US Food and Drug Administration and more than 80 others are

33 tes has been an important focus for the U.S. Food and Drug Administration and the 2016 Congressional

34 h certain glucose-lowering therapies, the US Food and Drug Administration and the Committee for Medic

35 ges in the regulatory guidelines by the U.S. Food and Drug Administration and the European Medical Ag

36 There were 46 algorithms that currently have Food and Drug Administration and/or Conformite Europeenn

37 hput screen of drugs approved by the FDA (US Food and Drug Administration) and identified entry inhib

38 to the public, manufacturer's websites, U.S. Food and Drug Administration, and Centers for Disease Co

39 Food and Drug Administration, and industry collaboration

40 isk Framework developed by the United States Food and Drug Administration; and quantitative approache

41 Food and Drug Administration approval as a qualitative d

42 tal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid

43 vectors in this study will likely gain U.S. Food and Drug Administration approval for commercializat

44 under way that will likely pave the way for Food and Drug Administration approval in the United Stat

45 rogrammed cell death 1 drugs, have led to US Food and Drug Administration approval of 2 anti-programm

46 diatric dosing guidelines and have led to US Food and Drug Administration approval of adult dosing do

47 These findings supported the U.S. Food and Drug Administration approval of gadobutrol-enha

48 or and an aromatase inhibitor (AI), given US Food and Drug Administration approval of three agents in

49 ine is experiencing a renaissance, with U.S. Food and Drug Administration approval recently being obt

50 bitril/valsartan within the first 2 years of Food and Drug Administration approval.

51 , have been universally accepted or obtained Food and Drug Administration approval.

52 g number of clinical trials and the first US Food and Drug Administration approvals of cell therapies

53 were based on the review of the evidence, US Food and Drug Administration approvals, and consensus wh

54 ctivity against SARS-CoV-2, but it is not US Food and Drug Administration approved and currently is b

55 Platinum segments are US Food and Drug Administration approved and provide benefi

56 In the field of dentistry, the US Food and Drug Administration approved BoNT-A for the tre

57 ms, are underrepresented among United States Food and Drug Administration approved drugs.

58 On August 16, 2019, the U.S. Food and Drug Administration approved expanding the indi

59 In 2012, the United States Food and Drug Administration approved magnetic sphincter

60 The Food and Drug Administration approved the first ICI, ipi

61 In 2012, the Food and Drug Administration approved the use of bedaqui

62 of only three chemokine receptors with a US Food and Drug Administration approved therapeutic agent,

63 e, an oral medication, is United States (US) Food and Drug Administration approved to treat CL caused

64 In 2012, the Food and Drug Administration approved use of bedaquiline

65 ainst C. burnetii infections but is not U.S. Food and Drug Administration approved.

66 Food and Drug Administration approved.

67 IMPs, composed of US Food and Drug Administration-approved 500nm carboxylated

68 Food and Drug Administration-approved agents and DCE-MRI

69 inistered an acute low dose of perampanel, a Food and Drug Administration-approved AMPA receptor (AMP

70 Food and Drug Administration-approved and CLIA-waived po

71 Manufacturers of US Food and Drug Administration-approved and commercially a

72 ly and in combination with other existing US Food and Drug Administration-approved anti-cancer modali

73 Bortezomib and carfilzomib are two Food and Drug Administration-approved anticancer drugs,

74 Bupropion, a Food and Drug Administration-approved antidepressant and

75 The Food and Drug Administration-approved antifungal agent,

76 telephone counseling sessions and choice of Food and Drug Administration-approved cessation medicati

77 en the high positivity rate as compared with Food and Drug Administration-approved currently availabl

78 Recently, Food and Drug Administration-approved cystic fibrosis pr

79 acy of maraviroc, an inhibitor of CCR5 and a Food and Drug Administration-approved drug against HIV i

80 Ponatinib, a necroptosis-inhibiting and Food and Drug Administration-approved drug for lymphocyt

81 Pioglitazone (Pio) is a Food and Drug Administration-approved drug for type-2 di

82 er, at the time of this writing, there is no Food and Drug Administration-approved drug for vitiligo.

83 fforts of scientists on repurposing existing Food and Drug Administration-approved drugs that inhibit

84 As Food and Drug Administration-approved drugs, the tetracy

85 oinformatics search for structurally similar Food and Drug Administration-approved drugs.

86 yclic antidepressants, or a drug that is not Food and Drug Administration-approved for their age.

87 s this concern, we examined the impact of US Food and Drug Administration-approved HDACi on the traff

88 , collectively termed JAK inhibitors, are US Food and Drug Administration-approved in a few autoimmun

89 Food and Drug Administration-approved in combination wit

90 The Food and Drug Administration-approved influenza A antivi

91 ended use population that reflected the U.S. Food and Drug Administration-approved instructions for u

92 y blinding periocular condition for which no Food and Drug Administration-approved medical therapy is

93 Food and Drug Administration-approved NA inhibitors enha

94 treatment option, including that for the now Food and Drug Administration-approved peanut OIT product

95 memories.SIGNIFICANCE STATEMENT There are no Food and Drug Administration-approved pharmacotherapies

96 Combinations of US Food and Drug Administration-approved PI with a pharmaco

97 Food and Drug Administration-approved prescribing inform

98 nvolvement of RT activity implicates already Food and Drug Administration-approved RT inhibitors as p

99 After an initial potency screening of 7 U.S. Food and Drug Administration-approved statins, we examin

100 Food and Drug Administration-approved stents and embolic

101 in neoplasia has led to development of U.S. Food and Drug Administration-approved targeted therapies

102 To date, there is no Food and Drug Administration-approved targeted therapy f

103 An example of a Food and Drug Administration-approved theranostic pair i

104 de with high morbidity and mortality, and no Food and Drug Administration-approved therapies.

105 There is still no US Food and Drug Administration-approved therapy for ALD, a

106 Food and Drug Administration-approved treatments are now

107 marked a new era for the field, with the US Food and Drug Administration approving patisiran, the fi

108 idis received expedited approval from the US Food and Drug Administration as a breakthrough drug for

109 nnaire (KCCQ) has been qualified by the U.S. Food and Drug Administration as a Clinical Outcome Asses

110 nd NDA 212643 for UCSF) were approved by the Food and Drug Administration as the first drug for PET i

111 opean medical device regulatory agencies, US Food and Drug Administration, as well as payers, that we

112 bdominal pain response, as defined by the US Food and Drug Administration: at least a 30% decrease in

113 s plus endocrine therapy submitted to the US Food and Drug Administration before Jan 1, 2019, in supp

114 r adult cancers that were approved by the US Food and Drug Administration between Jan 1, 2009, and De

115 results were interpreted using United States Food and Drug Administration breakpoints.

116 s fast, with automatic postprocessing and US Food and Drug Administration/CE clinical approval, it ca

117 le to perform and has recently received U.S. Food and Drug Administration clearance.

118 Food and Drug Administration cleared and well validated

119 ntibacterial resistance transmission, but no Food and Drug Administration-cleared assays for detectio

120 hs-cTnI and risk for adverse events, using 2 Food and Drug Administration-cleared hs-cTnI assays, an

121 ence of syphilis, the development of direct, Food and Drug Administration-cleared T. pallidum NAATs s

122 The Food and Drug Administration-defined primary efficacy en

123 formulations have been approved by the U.S. Food and Drug Administration during the last 30 years.

124 Initial implementation of the U.S. Food and Drug Administration EFS program has been succes

125 ch trials is also now permitted through U.S. Food and Drug Administration Emergency Use Authorization

126 nse or overall symptom relief, when using US Food and Drug Administration/European Medicines Agency r

127 llowing new data sources have been included: Food and Drug Administration (FDA) Adverse Event Reporti

128 The daily dose recommended by the US Food and Drug Administration (FDA) and European Medicine

129 Etest compared to that of BMD following U.S. Food and Drug Administration (FDA) and International Sta

130 ocedures, and working with the United States Food and Drug Administration (FDA) and other regulatory

131 On September 27-28, 2018 the Food and Drug Administration (FDA) and the Critical Path

132 diagnostic assay that receives United States Food and Drug Administration (FDA) approval can be a slo

133 led to their accelerated, tissue-agnostic US Food and Drug Administration (FDA) approval for adult an

134 n by Yersinia pestis, are needed, as past US Food and Drug Administration (FDA) approvals were not ba

135 The neurosteroid pregnenolone, a US Food and Drug Administration (FDA) approved drug, rescue

136 HD) are poor, and only ibrutinib has been US Food and Drug Administration (FDA) approved for this ind

137 Although the U.S. Food and Drug Administration (FDA) approved for transpor

138 nes should be offered treatments that are US Food and Drug Administration (FDA) approved in the upfro

139 ybin, which have been designated by the U.S. Food and Drug Administration (FDA) as "breakthrough ther

140 on new therapeutic agents approved by the US Food and Drug Administration (FDA) between 2009 and 2018

141 ute (CLSI) LC-MS C62-A document and the U.S. Food and Drug Administration (FDA) Bioanalytical Method

142 In 2016, the Food and Drug Administration (FDA) changed labeling rega

143 Concurrently, the Food and Drug Administration (FDA) conducted a postlicen

144 lication of the rules explains successful US Food and Drug Administration (FDA) de novo authorization

145 ustry-perceived barriers to such access, the Food and Drug Administration (FDA) developed a model dru

146 ls.gov, MEDLINE, and publicly available U.S. Food and Drug Administration (FDA) drug reviews, all rep

147 Although U.S. Food and Drug Administration (FDA) drugs are approved fo

148 ed molecular assays for SARS-CoV-2 under the Food and Drug Administration (FDA) Emergency Use Authori

149 While Food and Drug Administration (FDA) emergency use authori

150 kinase inhibitors have been approved by the Food and Drug Administration (FDA) for cancer chemothera

151 s have been developed and approved by the US Food and Drug Administration (FDA) for human use.

152 st to assays approved or cleared by the U.S. Food and Drug Administration (FDA) for in vitro diagnost

153 known about the evidence required by the U.S.Food and Drug Administration (FDA) for new approvals of

154 thority, and searched the homepage of the US Food and Drug Administration (FDA) for pregnancy exposur

155 Both treatments are approved by the US Food and Drug Administration (FDA) for r/r ALL (CD19CAR

156 e treponemal tests currently approved by the Food and Drug Administration (FDA) for the diagnosis of

157 d emergency use authorization (EUA) from the Food and Drug Administration (FDA) for the diagnosis of

158 The U.S. Food and Drug Administration (FDA) has granted emergency

159 The US Food and Drug Administration (FDA) has led the Sequencin

160 The US Food and Drug Administration (FDA) has provided guidance

161 -arrhythmic drug that was approved by the US Food and Drug Administration (FDA) in 1985.

162 Food and Drug Administration (FDA) in 1998.

163 ailable in Europe but is not approved by the Food and Drug Administration (FDA) in the United States.

164 C-containing vaping products examined by the Food and Drug Administration (FDA) in this investigation

165 A major challenge for the US Food and Drug Administration (FDA) is to achieve an appr

166 linical concerns such that the United States Food and Drug Administration (FDA) is warning on the use

167 The US Food and Drug Administration (FDA) issued a new proposed

168 of each vaccine from phase 1 through to U.S. Food and Drug Administration (FDA) licensure was tracked

169 expedition into the uncharted waters of the Food and Drug Administration (FDA) new-drug application

170 Neither the Food and Drug Administration (FDA) nor the Clinical and

171 d hyaluronidase-zzxf) was approved by the US Food and Drug Administration (FDA) on June 29, 2020.

172 Food and Drug Administration (FDA) plays in its regulati

173 cs are connected with the role that the U.S. Food and Drug Administration (FDA) plays in its regulati

174 The US Food and Drug Administration (FDA) primary end point was

175 pioid-tolerant patients, are subject to a US Food and Drug Administration (FDA) Risk Evaluation and M

176 suppression at 48 weeks according to the US Food and Drug Administration (FDA) snapshot analysis.

177 stant bacteria decreased over time following Food and Drug Administration (FDA) TCS bans.

178 Food and Drug Administration (FDA) through new drug appl

179 nd the Ophthalmic Devices Panel (ODP) of the Food and Drug Administration (FDA) to determine whether

180 ted emergency use authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-

181 Food and Drug Administration (FDA) warned that administr

182 Adverse event reports submitted to the US Food and Drug Administration (FDA) were analyzed to map

183 Laboratory Standards Institute (CLSI), U.S. Food and Drug Administration (FDA), and European Committ

184 uropean Medicines Agency (EMA), 16 by the US Food and Drug Administration (FDA), and ten by the Japan

185 am-avibactam is not yet approved by the U.S. Food and Drug Administration (FDA), clinicians can admin

186 or Disease Control and Prevention and the US Food and Drug Administration (FDA), respectively.

187 es, and for government agencies, such as the Food and Drug Administration (FDA), to secure safe use o

188 proximately 330-fold higher potency than the Food and Drug Administration (FDA)-approved anti-TcdB mo

189 Based on these data, a US Food and Drug Administration (FDA)-approved clinical tri

190 y used human brain tumor cell line to screen Food and Drug Administration (FDA)-approved compounds th

191 This compound is structurally related to the Food and Drug Administration (FDA)-approved drug fluoxet

192 Preclinical evidence with nilotinib, a US Food and Drug Administration (FDA)-approved drug for leu

193 C transgenic mice using AAV-PKR-K296R or the Food and Drug Administration (FDA)-approved drug metform

194 In this study, an Food and Drug Administration (FDA)-approved drug, diflun

195 ase and (iii) the known relationship between Food and Drug Administration (FDA)-approved drugs and di

196 Food and Drug Administration (FDA)-approved gadolinium-b

197 at 1-hour posttransplant with Anakinra, a US Food and Drug Administration (FDA)-approved IL-1R antago

198 However, there are currently no Food and Drug Administration (FDA)-approved pharmacother

199 There are now two US Food and Drug Administration (FDA)-approved products ava

200 Food and Drug Administration (FDA)-approved remyelinatin

201 ssing approximately 12,000 clinical-stage or Food and Drug Administration (FDA)-approved small molecu

202 A lead example is colchicine, a US Food and Drug Administration (FDA)-approved treatment fo

203 scope of the problem there are currently no Food and Drug Administration (FDA)-approved treatments.

204 Food and Drug Administration (FDA)-approved vaccine labe

205 es or vaccine vectors.IMPORTANCE To date, no Food and Drug Administration (FDA)-approved vaccines are

206 bacterial resistance transmission, but no US Food and Drug Administration (FDA)-cleared assays for de

207 ct testing as regulated by the United States Food and Drug Administration (FDA).

208 e exceeds 0.5 ng/mL as recommended by the US Food and Drug Administration (FDA).

209 Food and Drug Administration (FDA).

210 of the combination at the request of the US Food and Drug Administration (FDA).

211 oc interim analysis at the request of the US Food and Drug Administration (FDA).

212 rapid syphilis test currently cleared by the Food and Drug Administration (FDA).

213 HIV-1 RNA <50 copies/mL; intent-to-treat; US Food and Drug Administration [FDA] snapshot) at week 48;

214 tylase inhibitors (HDACi) approved by the US Food and Drug Administration for cutaneous T-cell lympho

215 ility Device Experience database from the US Food and Drug Administration for events related to menst

216 ranted Emergency Use Authorization by the US Food and Drug Administration for hospitalized COVID-19 p

217 There are 3 therapies approved by the US Food and Drug Administration for managing ATTR amyloidos

218 rteries have recently been cleared by the US Food and Drug Administration for marketing, and several

219 ation strategy (REMS) program imposed by the Food and Drug Administration for mifepristone.

220 noquine (TQ) was recently approved by the US Food and Drug Administration for prophylaxis of malaria

221 ene ciloleucel (axi-cel) was approved by the Food and Drug Administration for relapsed aggressive B-c

222 Duvelisib was approved by the Food and Drug Administration for relapsed or refractory

223 ntly, the first agent was approved by the US Food and Drug Administration for steroid-refractory cGVH

224 drugs that have already been approved by the Food and Drug Administration for targeting mRNAs and dis

225 It has recently been approved by the Food and Drug Administration for the management of compl

226 Food and Drug Administration for the management of moder

227 er the European Medicines Agency or the U.S. Food and Drug Administration for the management of moder

228 omutilin antibiotic that was approved by the Food and Drug Administration for the treatment of CABP i

229 hibitors have been developed and approved by Food and Drug Administration for the treatment of non-sm

230 ombopag (EPAG) received approval from the US Food and Drug Administration for the treatment of refrac

231 1PR5, was approved in March, 2019, by the US Food and Drug Administration for the treatment of relaps

232 HA or EPA alone have been approved by the US Food and Drug Administration for treating very high trig

233 Tocilizumab (anti-IL-6R) is approved by the Food and Drug Administration for treatment of cytokine s

234 treatment that has been approved by the U.S. Food and Drug Administration for treatment-resistant dep

235 an Kv11.1 channel blocker approved by the US Food and Drug Administration for use in the treatment of

236 Although US Food and Drug Administration guidelines require that pot

237 portant and highly recommended in current US Food and Drug Administration guidelines.

238 Food and Drug Administration has approved two microbial

239 The US Food and Drug Administration has indicated that this cir

240 The Food and Drug Administration has issued a black box warn

241 toxicity elicits severe side effects and the Food and Drug Administration has issued many warnings ab

242 As such, the US Food and Drug Administration has published a guidance to

243 with those of the regulatory agencies of US Food and Drug Administration, Health Canada and Food Sta

244 Center for Toxicological Research of the US Food and Drug Administration hosted a workshop to discus

245 antiandrogenic drug that was approved by the Food and Drug Administration in 2012 to treat patients w

246 Conversely, the iStent, approved by the Food and Drug Administration in 2012, increased to repre

247 Obeticholic acid was approved by the US Food and Drug Administration in 2016 as a second-line tr

248 efits of DCS observed in LF to inform the US Food and Drug Administration in a device registration de

249 possible mechanisms of harm, the role of the Food and Drug Administration in a setting like this one,

250 -arm, first-in-human, investigator-initiated Food and Drug Administration Investigational Device Exem

251 nd after transfusion through the traditional Food and Drug Administration investigational new drug pa

252 biomarker approved by the FDA (United States Food and Drug Administration) is the prostate specific a

253 s for label-free identification of PG by the Food and Drug Administration, it becomes crucial to educ

254 Despite the Food and Drug Administration label recommendation to avo

255 th breast implants followed by United States Food and Drug Administration large postapproval studies

256 A US Food and Drug Administration-led environmental assessmen

257 Results suggest that the US Food and Drug Administration made no progress in setting

258 Food and Drug Administration mandated CT studies to unde

259 In 2016, the US Food and Drug Administration mandated the labeling of ad

260 g women, due in part to important efforts by Food and Drug Administration, National Institutes of Hea

261 clinic, which has led to approval by the US Food and Drug Administration of multiple agents in sever

262 st recent targeted agents approved by the US Food and Drug Administration, olaparib for germline BRCA

263 ciation between label restrictions by the US Food and Drug Administration on first-line immunotherapy

264 therapies, and are awaiting approval by the Food and Drug Administration or have been recently appro

265 eumonia, but it was not approved by the U.S. Food and Drug Administration owing, in part, to its stru

266 filled potentially teratogenic or fetotoxic (Food and Drug Administration pregnancy category D/X) car

267 cline was noninferior to linezolid using the Food and Drug Administration primary endpoint of early c

268 The US Food and Drug Administration primary endpoint was an ear

269 In 2015, the US Food and Drug Administration published revised guidance

270 The US Food and Drug Administration recommends assessing CABP s

271 The Food and Drug Administration recommends that food worker

272 T was a prospective, multicenter, single-arm Food and Drug Administration-regulated investigational d

273 herefore, there is urgent need for robust US Food and Drug Administration regulation of all tobacco p

274 d units, a value far exceeding the recent US Food and Drug Administration-required cutoff of 12.0 for

275 Food and Drug Administration review data, and product la

276 hy Clinical Trial), published literature, US Food and Drug Administration review documents, healthcar

277 these antimicrobials were approved under the Food and Drug Administration's Animal Efficacy Rule.

278 a unique regulatory approach based on the US Food and Drug Administration's Animal Rule.

279 The Food and Drug Administration's Center for Drugs and Radi

280 sing ring Estring(R)) is described in the US Food and Drug Administration's Dissolution Methods Datab

281 g eculizumab worldwide were obtained from US Food and Drug Administration safety databases and the me

282 HIV-1-RNA <50 copies/mL (responders) by the Food and Drug Administration Snapshot algorithm (intent-

283 with HIV-1 RNA >=50 copies/mL at week 48 (US Food and Drug Administration Snapshot algorithm) in the

284 copies per milliliter or higher at week 48 (Food and Drug Administration snapshot algorithm).

285 ess than 50 copies per mL at week 144, by US Food and Drug Administration Snapshot algorithm, analyse

286 less than 50 copies per mL at week 96 by US Food and Drug Administration snapshot algorithm, with a

287 an 50 HIV-1 RNA copies per mL at week 48 (US Food and Drug Administration snapshot algorithm; non-inf

288 We used a US Food and Drug Administration snapshot approach and a mar

289 nts with <50 HIV-1 RNA copies/mL at week 48 (Food and Drug Administration snapshot approach; non-infe

290 een to identify compounds approved by the US Food and Drug Administration that reduce activity of cas

291 United States and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of

292 surgery; oncologists; basic scientists; the Food and Drug Administration; the Centers for Medicare a

293 ents with IPF.Methods: Working with the U.S. Food and Drug Administration through the Drug Developmen

294 s of Health, our academic societies, and the Food and Drug Administration to continue support of thes

295 postmarketing resource established by the US Food and Drug Administration to support assessment of th

296 no single agent has been approved by the US Food and Drug Administration to treat EoE.

297 erum chemistry and hematology), according to Food and Drug Administration toxicity scoring, to assess

298 A second phase III Food and Drug Administration trial is ongoing.

299 "Emergency Use Authorization" from the U.S. Food and Drug Administration, were discussed.

300 ta-targeted agents have been approved by the Food and Drug Administration, with additional agents, mo