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

1 ssued as a guidance for industry and for the Food and Drug Administration.

2 pilepsy Society, Epilepsy Foundation, and US Food and Drug Administration.

3 drug applications have been approved by the Food and Drug Administration.

4 ed all quality control guidelines set by the Food and Drug Administration.

5 bine, an anticonvulsant approved by the U.S. Food and Drug Administration.

6 rug (IND) applications submitted to the U.S. Food and Drug Administration.

7 e only drug approved for treatment by the US Food and Drug Administration.

8 o support approval of this agent by the U.S. Food and Drug Administration.

9 d commodities regulated by the United States Food and Drug Administration.

10 ylene mesh has come under scrutiny by the US Food and Drug Administration.

11 Tumor Drug Development Coalition and the US Food and Drug Administration, a standardized brain tumor

12 lts from ICUs than from non-ICUs passed 2016 Food and Drug Administration accuracy criteria (p < 10)

13 m the same patient by applying the 2016 U.S. Food and Drug Administration accuracy criteria, determin

14 aggregated knowledge-enhanced database, the Food and Drug Administration Adverse Event Reporting Sys

15 In this study, we analyzed a normalized US Food and Drug Administration Adverse Event Reporting Sys

16 The Food and Drug Administration Adverse Event Reporting Sys

17 egory B anthelmintic drug approved by the US Food and Drug Administration, also inhibited ZIKV replic

18 We summarize findings from independent US Food and Drug Administration analyses of drug resistance

19 Food and Drug Administration and Centers for Medicare an

20 Food and Drug Administration and Centers for Medicare an

21 Studies of drugs approved by the U.S. Food and Drug Administration and commonly prescribed by

22 ith the fish intake limit proposed by the US Food and Drug Administration and Environmental Protectio

23 In this editorial, authors from the US Food and Drug Administration and European Medicines Agen

24 rials, with six approved for usage by the US Food and Drug Administration and one by the EU.

25 ions, as reflected by the guidance of the US Food and Drug Administration and other regulatory agenci

26 rview, roles, and responsibilities of the US Food and Drug Administration and the European Medicines

27 er being under review for approval by the US Food and Drug Administration and the European Medicines

28 , Embase, Cochrane Central Register, Lilacs, Food and Drug Administration, and European Medicines Age

29 Food and Drug Administration, and European Medicines Age

30 Current US Food and Drug Administration- and European Medicines Age

31 Food and Drug Administration approaches to dissemination

32 y, protected by monopoly rights awarded upon Food and Drug Administration approval and by patents.

33 Following the US Food and Drug Administration approval for laparoscopic g

34 luding pembrolizumab, have recently received Food and Drug Administration approval for the treatment

35 mune checkpoint inhibitor have received U.S. Food and Drug Administration approval for treatment of a

36 inhibitors (HPIs) were made available by US Food and Drug Administration approval in 2012 for vismod

37 eived breakthrough designation and recent US Food and Drug Administration approval in combination wit

38 ours after stroke onset, despite the lack of Food and Drug Administration approval in the 3- to 4.5-h

39 treated at Stanford University following US Food and Drug Administration approval of ibrutinib; 7 (6

40 The recent Food and Drug Administration approval of immunogenic onc

41 Recent US Food and Drug Administration approval of such agents for

42 dults with cancer that led to the initial US Food and Drug Administration approval of that agent from

43 ical studies and recently in humans, with US Food and Drug Administration approval of the oncolytic h

44 on medication used, despite its lacking U.S. Food and Drug Administration approval to treat ophthalmi

45 jections increased from 0 of 4488 (before US Food and Drug Administration approval) to 429 of 5253 po

46 lymphoblastic leukemia, resulting in its US Food and Drug Administration approval.

47 rugs from different classes, preferably with Food and Drug Administration approval.

48 atment of a variety of cancers and led to US Food and Drug Administration approvals for patients with

49 coming a first-line treatment option with US Food and Drug Administration approvals for various tumor

50 The recent US Food and Drug Administration approvals of novel targeted

51 New supplemental US Food and Drug Administration approvals, new off-label in

52 ied most often, and one, adalimumab, is U.S. Food and Drug Administration approved for the treatment

53 peutics, mepolizumab and reslizumab, were US Food and Drug Administration approved for the treatment

54 Duloxetine is US Food and Drug Administration approved for treatment of m

55 ormulation of the fumaric acid ester that is Food and Drug Administration approved for treatment of r

56 On Aug 14, 2014, the US Food and Drug Administration approved the antiangiogenes

57 In February, 2017, the US Food and Drug Administration approved the blood infectio

58 In April 2016, the Food and Drug Administration approved the first biosimil

59 In July 2015, the US Food and Drug Administration approved the first of a new

60 Fenoldopam, which is FDA (Food and Drug Administration) approved to treat renal hy

61 resistant TB (MDR-TB), repurposing FDA (U.S. Food and Drug Administration) -approved drugs for develo

62 mammograms were generated by using the U.S. Food and Drug Administration-approved "C-View" software

63 Additionally, a screen of US Food and Drug Administration-approved (FDA-approved) dru

64 Riluzole, the only US Food and Drug Administration-approved ALS drug, prolongs

65 Food and Drug Administration-approved anti-human cytomeg

66 that are resistant to one or both classes of Food and Drug Administration-approved anti-influenza dru

67 Clofazimine is a weakly basic, Food and Drug Administration-approved antibiotic recomme

68 Clemastine, a Food and Drug Administration-approved antimuscarinic com

69 d rimantadine) are one of the two classes of Food and Drug Administration-approved antiviral drugs us

70 stigate the comparative effectiveness of the Food and Drug Administration-approved BVS versus metalli

71 We show that the US Food and Drug Administration-approved CDK4/6 kinase inhi

72 novel drug-repurposing screening to identify Food and Drug Administration-approved chemotherapeutic c

73 This approach led us to identify the U.S. Food and Drug Administration-approved compound protamine

74 ld clinical effectiveness and safety of U.S. Food and Drug Administration-approved devices.

75 event risk did not differ between current US Food and Drug Administration-approved dosing of 100-200

76 nzoate (NaB), a metabolite of cinnamon and a Food and Drug Administration-approved drug against urea

77 In addition, a Food and Drug Administration-approved drug ameliorates t

78 s of Tg mice and their WT littermates to the Food and Drug Administration-approved drug FTY720 (fingo

79 Adenosine is a Food and Drug Administration-approved drug, but very lit

80 A small molecule inhibitor of Pho84, a Food and Drug Administration-approved drug, inhibits TOR

81 Resource database revealed that dasatinib, a Food and Drug Administration-approved drug, potently bin

82 ibitors were identified through screening US Food and Drug Administration-approved drugs and clinical

83 gs (IMiDs) lenalidomide and pomalidomide are Food and Drug Administration-approved drugs for the trea

84 rformed a high-throughput screen to identify Food and Drug Administration-approved drugs or other bio

85 Using this network, we identified four Food and Drug Administration-approved drugs that selecti

86 a small molecule collection, including 1250 Food and Drug Administration-approved drugs, in a novel

87 st that PGI2 and its analogue iloprost, both Food and Drug Administration-approved drugs, may be usef

88 e substrate is 4.5, which is in the range of Food and Drug Administration-approved drugs.

89 Purpose Sorafenib is currently the only Food and Drug Administration-approved first-line therapy

90 Daratumumab is a U.S. Food and Drug Administration-approved high-affinity mono

91 the Aptima HIV-1 RNA test (Aptima) and 20 US Food and Drug Administration-approved HIV immunoassays u

92 Randomized controlled trials of recent US Food and Drug Administration-approved immune checkpoint

93 ials.gov for phase II to IV cancer trials of Food and Drug Administration-approved immunotherapy drug

94 some activation: pharmacologic (using the US Food and Drug Administration-approved inhibitor ibrutini

95 Dasatinib, a Food and Drug Administration-approved inhibitor of Src t

96 We validated our approach using the Food and Drug Administration-approved iron oxide nanopar

97 evaluate lifetime cost-effectiveness of the Food and Drug Administration-approved lower-dose ticagre

98 We determined all US Food and Drug Administration-approved manufacturers for

99 since the approval of riluzole, the only US Food and Drug Administration-approved medication to mode

100 ublic health and social problem without a US Food and Drug Administration-approved medication.

101 Current US Food and Drug Administration-approved multiplex panels t

102 gression-free survival (PFS) in trials of US Food and Drug Administration-approved oncology immunothe

103 reactive metabolites (RM) in a large set of Food and Drug Administration-approved oral medications a

104 PDS mutations were potently inhibited by the Food and Drug Administration-approved p110delta inhibito

105 protein, eosinophil peroxidase, and many US Food and Drug Administration-approved peptidergic drugs

106 public health problem for which there are no Food and Drug Administration-approved pharmacotherapies.

107 ons that differ from those of currently U.S. Food and Drug Administration-approved pharmacotherapies.

108 s is an institutional review board- and U.S. Food and Drug Administration-approved prospective physic

109 er observational clinical trial following an Food and Drug Administration-approved protocol.

110 Evidence supports the use of US Food and Drug Administration-approved serologic tests, s

111 Administration of a U.S. Food and Drug Administration-approved serotonin agonist

112 Yet no Food and Drug Administration-approved stem cell therapie

113 Today, more than 100 Food and Drug Administration-approved steroidal agents a

114 ficance of the findings is the basis of 2 US Food and Drug Administration-approved studies comparing

115 Although there are no Food and Drug Administration-approved targeted therapies

116 Botulinum neurotoxin B is a Food and Drug Administration-approved therapeutic toxin.

117 e made rapid advances, resulting in multiple Food and Drug Administration-approved therapeutics that

118 Cyclosporine and lifitegrast, the 2 US Food and Drug Administration-approved therapies, inhibit

119 r analysis; g differentiated docetaxel (a US Food and Drug Administration-approved therapy) from pred

120 ative assays, combined with the absence of a Food and Drug Administration-approved therapy.

121 (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valv

122 and permanent hearing loss, for which no US Food and Drug Administration-approved treatment is curre

123 ased inspections and communication by the US Food and Drug Administration are occurring, facilitating

124 type I anti-CD20 antibody approved by the US Food and Drug Administration as maintenance treatment of

125 ing was approved in October, 2014, by the US Food and Drug Administration based on the results of the

126 nticancer drugs that were approved by the US Food and Drug Administration between 1996 and 2012.

127 Recent changes to the U.S. Food and Drug Administration boxed warning for metformin

128 Purpose In March 2007, a US Food and Drug Administration boxed warning was issued fo

129 The Food and Drug Administration Center for Devices and Radi

130 Food and Drug Administration, Centers for Medicare and M

131 to generate the data necessary to support US Food and Drug Administration clearance of new diagnostic

132 5 CTCs at baseline, </= 4 at 13 weeks-the US Food and Drug Administration cleared response measure);

133 A non-invasive, US Food and Drug Administration-cleared device (Neuro-Stim,

134 is study was to assess the potential of U.S. Food and Drug Administration-cleared devices designed fo

135 indolent threshold (ultralow risk) of the US Food and Drug Administration-cleared MammaPrint 70-gene

136 FFDM images were processed with U.S. Food and Drug Administration-cleared software, and the M

137 tam vs doripenem was demonstrated for the US Food and Drug Administration co-primary endpoints of (1)

138 that hedgehog inhibitors approved by the US Food and Drug Administration could be used for the treat

139 acological c-MPL agonists approved by the US Food and Drug Administration could deliver both signals

140 A public safety communication issued by the Food and Drug Administration declared that citalopram do

141 copies per mL at week 24 according to the US Food and Drug Administration-defined snapshot algorithm.

142 mpetition and Innovation Act of 2009, the US Food and Drug Administration established an abbreviated

143 trials of oncology drug approvals by the US Food and Drug Administration, European Medicines Agency,

144 ASCO, Friends of Cancer Research, and the US Food and Drug Administration examined specific eligibili

145 ts may have a better chance for success, the Food and Drug Administration facilitated a meeting on Fe

146 r life-threatening conditions can receive US Food and Drug Administration (FDA) accelerated approval

147 in an independent database derived from the Food and Drug Administration (FDA) Adverse Event Reporti

148 Food and Drug Administration (FDA) Adverse Event Reporti

149 safety studies that were required by the US Food and Drug Administration (FDA) and Australian Therap

150 The US Food and Drug Administration (FDA) and European Medicine

151 oncology drugs that were approved by the US Food and Drug Administration (FDA) and required pharmaco

152 all new cancer medicines approved by the US Food and Drug Administration (FDA) and the European Medi

153 Despite Food and Drug Administration (FDA) approval of hydroxyur

154 There are no Food and Drug Administration (FDA) approved drugs availa

155 On 1 September 2017, the US Food and Drug Administration (FDA) approved gemtuzumab o

156 Food and Drug Administration (FDA) approved sofosbuvir/v

157 dage closure (LAAC) was approved by the U.S. Food and Drug Administration (FDA) as a stroke preventio

158 All products fell within the US Food and Drug Administration (FDA) average bioequivalenc

159 Although in a recent ruling, the U.S. Food and Drug Administration (FDA) banned CPC from certa

160 ht new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010

161 The U.S. Food and Drug Administration (FDA) continually works tow

162 Four assays registered with the US Food and Drug Administration (FDA) detect programmed cel

163 The United States Food and Drug Administration (FDA) ensures that patients

164 ncin have recently been approved by the U.S. Food and Drug Administration (FDA) for the treatment of

165 e breast cancer and are approved by the U.S. Food and Drug Administration (FDA) for this indication.

166 -acting antiviral (DAA) regimens by the U.S. Food and Drug Administration (FDA) for treatment of chro

167 that pomalidomide, a drug approved by the US Food and Drug Administration (FDA) for treatment of mult

168 dised European Medicines Agency (EMA) and US Food and Drug Administration (FDA) guidance for adults w

169 were analytically validated on the basis of Food and Drug Administration (FDA) guidance.

170 The method was validated according to U.S. Food and Drug Administration (FDA) guidelines, which inc

171 The Food and Drug Administration (FDA) has mandated that war

172 The Food and Drug Administration (FDA) has the authority to

173 rug (nusinersen/Spinraza) was approved by US Food and Drug Administration (FDA) in late 2016 and seve

174 Evaluation and Research (CDER) within the US Food and Drug Administration (FDA) is tracking the use o

175 s consisted of all novel agents receiving US Food and Drug Administration (FDA) licensure 2005-2012 i

176 These include unnecessarily strict US Food and Drug Administration (FDA) limitations on how co

177 Register of Controlled Trials, CINAHL, U.S. Food and Drug Administration (FDA) materials, and refere

178 Medicine Agency (EMA) and the United States Food and Drug Administration (FDA) may provide summaries

179 vices are iteratively modified after initial Food and Drug Administration (FDA) Premarket Approval (P

180 In 2014, the US Food and Drug Administration (FDA) proposed to regulate

181 g beta2-agonists (LABAs) have led to many US Food and Drug Administration (FDA) regulatory activities

182 Since the Food and Drug Administration (FDA) released its draft gu

183 In 2016, the United States Food and Drug Administration (FDA) removed three food co

184 s to reconsider the manner in which the U.S. Food and Drug Administration (FDA) reviews diagnostic ra

185 Food and Drug Administration (FDA) reviews on Drugs@FDA.

186 e 1958, when Congress gave the United States Food and Drug Administration (FDA) the authority to ensu

187 modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds

188 The National Cancer Institute and the US Food and Drug Administration (FDA) use different criteri

189 . Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the European Foo

190 among novel therapeutics approved by the US Food and Drug Administration (FDA), and to examine wheth

191 itretin, an RA derivative approved by the US Food and Drug Administration (FDA), enhances RIG-I signa

192 This Perspective discusses how the US Food and Drug Administration (FDA), the United States Ph

193 tors, which have not been approved by the US Food and Drug Administration (FDA), to enhance appearanc

194 amined whether the off-target effects of the Food and Drug Administration (FDA)-approved anti-helmint

195 ved lymphoma cells using a library of 106 US Food and Drug Administration (FDA)-approved anticancer d

196 KBP12 and calcineurin, with low doses of the Food and Drug Administration (FDA)-approved compound Tac

197 We evaluated pirfenidone, a Food and Drug Administration (FDA)-approved drug for idi

198 Thus, we propose ACF, a US Food and Drug Administration (FDA)-approved drug for non

199 Furthermore, the US Food and Drug Administration (FDA)-approved drug pyrvini

200 are the targets of 475 ( approximately 34%) Food and Drug Administration (FDA)-approved drugs and ac

201 on its ability to identify known targets of Food and Drug Administration (FDA)-approved drugs and it

202 tion that could be targeted by repurposed US Food and Drug Administration (FDA)-approved drugs to tre

203 ing phasic GABA signalling using zolpidem, a Food and Drug Administration (FDA)-approved GABA-positiv

204 Until now, the Food and Drug Administration (FDA)-approved iron supplem

205 trations of gemcitabine and several other US Food and Drug Administration (FDA)-approved oncology dru

206 ok effect mandating use of the United States Food and Drug Administration (FDA)-approved protocol for

207 Hong et al advocate for use of additional US Food and Drug Administration (FDA)-approved safety measu

208 As of mid-2016, there are no US Food and Drug Administration (FDA)-approved T cell thera

209 Currently, no Food and Drug Administration (FDA)-approved therapeutics

210 approval of a new imaging agent by the U.S. Food and Drug Administration (FDA).

211 ts with advisors from the U.S. NHLBI and the Food and Drug Administration (FDA).

212 nd this is now under investigation by the US Food and Drug Administration (FDA).

213 ive medications have been approved by the US Food and Drug Administration for chronic weight manageme

214 microspheres have been approved by the U.S. Food and Drug Administration for colorectal liver metast

215 Sorafenib is approved by the US Food and Drug Administration for metastatic, radioactive

216 -MRI-conditional" (i.e., not approved by the Food and Drug Administration for MRI scanning).

217 already approved for clinical use by the US Food and Drug Administration for other conditions, it ha

218 ombination was recently approved by the U.S. Food and Drug Administration for patients homozygous for

219 sin and pralatrexate were approved by the US Food and Drug Administration for patients with relapsed/

220 id (OCA), which was recently approved by the Food and Drug Administration for PBC treatment, has demo

221 ve replacement (TAVR) was approved by the US Food and Drug Administration for severe aortic stenosis

222 , is a new targeted agent approved by the US Food and Drug Administration for the treatment of chroni

223 only 2 new drugs had been approved by the US Food and Drug Administration for the treatment of chroni

224 Midostaurin was recently approved by the US Food and Drug Administration for the treatment of FLT3-m

225 s reduce food intake and are approved by the Food and Drug Administration for the treatment of obesit

226 nisms of action have been approved by the US Food and Drug Administration for the treatment of relaps

227 ing GM-CSF has been recently approved by the Food and Drug Administration for the treatment of unrese

228 no commercial tests are cleared by the U.S. Food and Drug Administration for use with extragenital s

229 and the federal government including the US Food and Drug Administration, formed a group working tow

230 CLC with active controls submitted to the US Food and Drug Administration from January 1, 2003, throu

231 at (mMITT) population (in accordance with US Food and Drug Administration guidance), and the modified

232 Radiofrequency heating was within US Food and Drug Administration guidelines.

233 At this time, the United States Food and Drug Administration has approved three checkpoi

234 In addition, the Food and Drug Administration has convened 2 Advisory Com

235 The US Food and Drug Administration has recently approved a num

236 The Food and Drug Administration has suggested that duodenos

237 (68)Ga-DOTATATE approval by the U.S. Food and Drug Administration has triggered widespread cl

238 Although a qualified Food and Drug Administration health claim exists for nut

239 :4n-6), which were first permitted by the US Food and Drug Administration in 2001.

240 esulting in conditional approval by the U.S. Food and Drug Administration in 2014.

241 European Medicines Agency in 2009 and the US Food and Drug Administration in 2016.

242 None yet are cleared by the Food and Drug Administration in the United States, altho

243 cope of CVD nonadherence, describes key U.S. Food and Drug Administration initiatives, and identifies

244 The United States Food and Drug Administration is concerned about the pres

245 Due to accuracy concerns, the Food and Drug Administration issued guidances to manufac

246 When the US Food and Drug Administration judges the potential cardio

247 rtunity to use volumes of data to support US Food and Drug Administration labeling and practice guide

248 hich was provided on site, according to U.S. Food and Drug Administration labeling requirements.

249 her underdosed or overdosed, consistent with Food and Drug Administration labeling.

250 In October 2007, the Food and Drug Administration mandated significant revisi

251 In 2017, 4 drugs received US Food and Drug Administration marketing approval for acut

252 NSCLC) therapy, with 2 approvals from the US Food and Drug Administration of PD-1 inhibitors for seco

253 Alum is the only licensed adjuvant by Food and Drug Administration of USA used in many human v

254 nical trial applications submitted to the US Food and Drug Administration Office of Hematology and On

255 noscopes did not identify deviations from US Food and Drug Administration or manufacturer recommendat

256 the number of drugs being approved by the US Food and Drug Administration over time, have generated i

257 The US Food and Drug Administration plans a nationwide restrict

258 amyloid status based on the criteria in the Food and Drug Administration prescribing information for

259 Food and Drug Administration published new, more stringe

260 Food and Drug Administration published recommendations a

261 ific biomarker-approved by the United States Food and Drug Administration-qualifying a patient to rec

262 The US Food and Drug Administration recently endorsed end point

263 The Food and Drug Administration recently put additional res

264 or actual disposal, but no study reported US Food and Drug Administration-recommended disposal method

265 h generic switches, and complaints to the US Food and Drug Administration regarding generic products.

266 Biologics Evaluation and Research of the US Food and Drug Administration regulates biologics used fo

267 The system conforms to recently released Food and Drug Administration regulation that pertains to

268 tency requirement for IVIGs, as defined in a Food and Drug Administration regulation.

269 ies and volume deficits, but the proposed US Food and Drug Administration regulations may severely li

270 In order to conform to the US Food and Drug Administration's accepted guidelines for I

271 These reports originated at the US Food and Drug Administration's Adverse Event Reporting S

272 We evaluated the US Food and Drug Administration's boxed warning of ESAs use

273 Food and Drug Administration's Mini-Sentinel program.

274 fety in pregnancy and lactation using the US Food and Drug Administration's new Pregnancy and Lactati

275 mmendations and materials from the recent US Food and Drug Administration's Pediatric Advisory Commit

276 The results of our study support the U.S. Food and Drug Administration's removal of nitarsone from

277 The US Food and Drug Administration's updated nutrition labelin

278 National U.S. Food and Drug Administration Sentinel network.

279 50 copies per mL at week 48 as defined by US Food and Drug Administration snapshot algorithm (prespec

280 suppression at week 32 (as defined by the US Food and Drug Administration snapshot algorithm), protoc

281 mL of plasma HIV-1 RNA at week 48 (by the US Food and Drug Administration snapshot algorithm), with a

282 copies per mL at week 48 (assessed by the US Food and Drug Administration snapshot algorithm), with a

283 of less than 50 copies per mL at week 48 (US Food and Drug Administration snapshot algorithm), with a

284 pies per mL at week 48, as defined by the US Food and Drug Administration snapshot algorithm, with a

285 opies per mL at week 48 assessed with the US Food and Drug Administration Snapshot algorithm.

286 brane-active antibiotic approved by the U.S. Food and Drug Administration so far.

287 ) of GEN and two polymers approved by the US Food and Drug Administration: sodium hyaluronate and pol

288 vices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" d

289 the Academy of Nutrition and Dietetics, the Food and Drug Administration, the CDC, the USDA/Agricult

290 nal cohort study, was a commitment to the US Food and Drug Administration to assess the long-term saf

291 The final estimates used by the Food and Drug Administration to determine whether to gra

292 on the basis of special consideration by the Food and Drug Administration to respond to an outbreak o

293 rement results that were submitted to the US Food and Drug Administration to support the regulatory a

294 munosuppressant and has been approved by the Food and Drug Administration to treat refractory multipl

295 approval dates of the study drugs by the US Food and Drug Administration) to May 19, 2016.

296 In contrast, the US Food and Drug Administration traditionally requires stri

297 inhibitors that have been approved by the US Food and Drug Administration was reviewed and articles r

298 nical Trials, ClinicalTrials.gov, and the US Food and Drug Administration website for systematic revi

299 Trials submitted to the US Food and Drug Administration with more than 150 patients

300 The Food and Drug Administration would consider assessments