ライフサイエンスコーパス: regulatory agency

1 and the UK Medicines and Healthcare Products Regulatory Agency.

2 he maximum residue limits established by the regulatory agency.

3 erm may involve clinical trial validation by regulatory agencies.

4 th care quality consortia, and standards and regulatory agencies.

5 nd for approval of new therapeutic agents by regulatory agencies.

6 researchers, drug-development programs, and regulatory agencies.

7 e opioids because of possible sanctions from regulatory agencies.

8 e types of events that should be reported to regulatory agencies.

9 e coordination and cooperation with national regulatory agencies.

10 nslation and approval of (99m)Tc-PSMA I&S by regulatory agencies.

11 tant and may provide support for approval by regulatory agencies.

12 reparing product data for review by national regulatory agencies.

13 to patient safety and is the expectation by regulatory agencies.

14 ng approval continues to pose challenges for regulatory agencies.

15 esity, has led to investigations by European regulatory agencies.

16 if the intake levels exceed the limit set by regulatory agencies.

17 lished among the pharmaceutical industry and regulatory agencies.

18 uld be rigorously evaluated by international regulatory agencies.

19 mine the scientific capacity of research and regulatory agencies.

20 trials for macular diseases as requested by regulatory agencies.

21 ufacturing practices regulations enforced by regulatory agencies.

22 reative collaboration between scientists and regulatory agencies.

23 imicrobial stewardship, data scientists, and regulatory agencies.

24 achacas, affording security to consumers and regulatory agencies.

25 ve the maximum residue levels allowed by the regulatory agencies.

26 ical companies, patient representatives, and regulatory agencies.

27 e companies, aeroallergen manufacturers, and regulatory agencies.

28 ogical drug development and is expected from regulatory agencies.

29 andard range of IOP-measuring methods set by regulatory agencies.

30 ialty professional organization and national regulatory agencies.

31 tists, and representatives from industry and regulatory agencies.

32 re and has been the subject of guidance from regulatory agencies.

33 protection has the highest priority, such as regulatory agencies.

34 to consumers and providing an alternative to regulatory agencies.

35 events on social media than to clinicians or regulatory agencies.

36 rovide important messages for clinicians and regulatory agencies.

37 w the PeDAL could be used by applicators and regulatory agencies.

38 rant the attention of the general public and regulatory agencies.

39 utical ingredients approved by FDA and other regulatory agencies.

40 battery is a major challenge to industry and regulatory agencies.

41 fortified foods is mandatory by many global regulatory agencies.

42 s the utility of DNA barcoding as a tool for regulatory agencies.

43 y liver disease (NAFLD) has been approved by regulatory agencies.

44 ented by clinicians, academia, industry, and regulatory agencies.

45 r more stringent drinking water standards by regulatory agencies.

46 ntion from researchers, drug developers, and regulatory agencies.

47 ally below benchmark values commonly used by regulatory agencies.

48 in antifibrotic trials will be acceptable to regulatory agencies.

49 utical industry and requirements of national regulatory agencies.

50 rdized aggregate safety reports submitted to regulatory agencies.

51 against the requirements and suggestions of regulatory agencies.

52 an EBOV-targeted vaccine by European and US regulatory agencies.

53 ed for approval of new therapeutic agents by regulatory agencies.

54 epted by several international water quality regulatory agencies.

55 nicians, public health authorities, and drug regulatory agencies), a multiplicity of endpoints must b

56 Food and Drug Administration (FDA) and other regulatory agencies about developing criteria to evaluat

57 s with the air permitting process and inform regulatory agencies about potential permitting pathways

58 ernment (including both research funding and regulatory agencies), academia, and patient groups to di

59 technical advisory groups (NITAGs), national regulatory agencies, academia, and United Nations organi

60 entatives from 41 organisations representing regulatory agencies, academia, the pharmaceutical indust

61 Regulatory agencies accept these endpoints for full drug

62 anding of the pathogenesis of IgAN, and with regulatory agencies accepting changes in proteinuria and

63 ularly following the issuance of guidance by regulatory agencies advising caution in their use in cer

64 ns has become a challenge for scientists and regulatory agencies alike.

65 rmaceutical industry, financial markets, and regulatory agencies alike.

66 recognized by professional associations and regulatory agencies alike.

67 this body of work would need to engage with regulatory agencies and bodies that formulate guidelines

68 approved for cancer-related patient usage by regulatory agencies and discuss approaches to improve th

69 verity, stress on resources and influence of regulatory agencies and local factors are responsible fo

70 gineered nanomaterials in consumer products, regulatory agencies and other research organizations hav

71 So far, thirteen STOs have been approved by regulatory agencies and over one hundred of them are in

72 organizations, bio-pharmaceutical industry, regulatory agencies and policy makers.

73 These tools are increasingly recognized by regulatory agencies and professional medical societies,

74 Regulatory agencies and professional organizations recom

75 recommended by clinical practice guidelines, regulatory agencies and public health agencies for the i

76 de first the approval of the new drug by the regulatory agencies and second the introduction of a mar

77 vity and areas in need of clarification from regulatory agencies and societies.

78 interventions, and we call for researchers, regulatory agencies and sponsors to support and facilita

79 utics including in the area of inflammation, regulatory agencies and the pharmaceutical industry must

80 ed, and their use elicits concerns from both regulatory agencies and the public because PFAS are pers

81 These new tools benefit regulatory agencies and the stored food products industr

82 enters, organ procurement organizations, and regulatory agencies and to benefit patients in decision-

83 Close collaboration between academia, regulatory agencies and vaccine producers will facilitat

84 ovals (the Medicines and Healthcare products Regulatory Agency); and online disease awareness (Google

85 re, consultation with vaccine developers and regulatory agencies, and a collaborative workshop that g

86 effective work group representing industry, regulatory agencies, and academic and federal science, a

87 at typically assists in executing the trial, regulatory agencies, and academicians, provides inadequa

88 dentialing bodies, accrediting boards, state regulatory agencies, and care delivery organizations est

89 or reduced toxicity testing costs, demand by regulatory agencies, and ethical or moral concerns.

90 fore their marketing or formal approval from regulatory agencies, and for this reason their efficacy

91 ell lung cancer, discuss challenges faced by regulatory agencies, and highlight paradoxical lessons t

92 ities, for example, governmental funding and regulatory agencies, and industry and clinician scientis

93 by research groups in academia, industry and regulatory agencies, and its strengths are highlighted b

94 , several of which have now been approved by regulatory agencies, and nanoparticles containing mRNAs

95 of providers along with government entities, regulatory agencies, and national organizations contribu

96 coordinated action across private companies, regulatory agencies, and non-profit organizations to exp

97 Representatives from academia, industry, regulatory agencies, and patient advocacy groups convene

98 Representatives from academia, industry, regulatory agencies, and patient groups convened in Marc

99 onsensus of experts from academia, industry, regulatory agencies, and patient representatives to adva

100 sues, the hope is that commercial companies, regulatory agencies, and professional societies can come

101 akeholders include, inter alia, governments, regulatory agencies, and professionals working in antibi

102 s necessitates collaboration among patients, regulatory agencies, and researchers.

103 actions between various medical specialties, regulatory agencies, and researchers.

104 health providers, public and private payers, regulatory agencies, and standards-setting organizations

105 laws and lawmakers, including legislatures, regulatory agencies, and the courts.

106 Critical care practitioners, regulatory agencies, and the pharmaceutical industry agg

107 cacy, safety, and claims are not assessed by regulatory agencies, and there is uncertainty about thei

108 on, the UK Medicines and Healthcare Products Regulatory Agency, and pharmaceutical companies.

109 trials and culminated in the recent federal regulatory-agency approvals of multiple clinical HSC gen

110 We recommend that regulatory agencies approve AEDs for the treatment of sp

111 As a result, no regulatory agency approved disease modifying OA drugs ar

112 A regulatory agencies-approved assay was used to assess Ig

113 a component of the inflammasome complex, to regulatory agency-approved IL-1-neutralizing biologic dr

114 Although there remain no regulatory agency-approved therapies for HHT, multiple l

115 e main precursor of acrylamide formation, as regulatory agencies are actively seeking to impose limit

116 ns and Web sites of various governmental and regulatory agencies are also reviewed.

117 Regulatory agencies are considering non-abstinent outcom

118 tical industry can influence governments and regulatory agencies are discussed, and methods by which

119 Federal regulatory agencies are further urging the use of advanc

120 pharmaceutical research and development, and regulatory agencies are increasingly requesting data on

121 nd lysins, dialogues between researchers and regulatory agencies are necessary to publish guidelines

122 Although recommendations and approval by regulatory agencies are often based on programmed death

123 Concurrently, many regulatory agencies are publishing criteria used in prac

124 Biotechnological companies and regulatory agencies are pursuing the complete characteri

125 US and European regulatory agencies are recommending that sponsors study

126 mAbs approved by regulatory agencies are selected from IgG1, IgG2, and Ig

127 on, the European Medicines Agency, and other regulatory agencies around the world.

128 It could be supported by regulatory agencies as a metric for quality care or to s

129 ogic complete response (pCR) is supported by regulatory agencies as a surrogate end point for long-te

130 This is important information for regulatory agencies as they regulate ENDS.

131 accepted by the pharmaceutical industry and regulatory agencies, as well as discuss recent advances

132 ment, though it is not routinely reported by regulatory agencies, as wildfire impacts on fluvial netw

133 marketing authorization by at least 1 other regulatory agency at a median (IQR) delay of 12.1 (17.7)

134 ies can be useful for both the consumers and regulatory agencies because it confirms the elevated sta

135 ted in the Medicines and Healthcare products Regulatory Agency becoming an independent national regul

136 By 2003, regulatory agencies began warning the public of unrecogn

137 pically defined as clinically significant by regulatory agencies, but risk factors for rapid 15-lette

138 ed through the effort of either (1) regional regulatory agencies by sharing and combining raw test da

139 Regulatory agencies consider PROs part of their evaluati

140 representatives from academia, industry, and regulatory agencies convened to consider the guidance in

141 Regulatory agencies could reinforce the FDA warning, and

142 Without increased access to regulatory agency data, publication bias will continue t

143 s study, we searched 33 US state oil and gas regulatory agency databases and identified records usefu

144 014, as well as other systematic reviews and regulatory agencies documentation.

145 marketing authorization by an international regulatory agency due to unfavorable benefit-to-risk ass

146 additional inhibitors were approved by other regulatory agencies during that time.

147 Few analytes targeted by regulatory agencies (e.g., benzene or toluene) were obse

148 Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administ

149 We suggest that regulatory agencies (eg, US Food and Drug Administration

150 Public health authorities, regulatory agencies, food producers, and food processors

151 ep towards a harmonized approach accepted by regulatory agencies for assessing nanopesticides.

152 gnostic platform in hospitals and for use by regulatory agencies for better control of health-risks a

153 d not only by food manufacturers but also by regulatory agencies for better control of potential heal

154 approved by both US and European Commission regulatory agencies for clinical use, extends survival o

155 common bioaccumulation cutoff values used by regulatory agencies for donepezil, sertraline, norsertra

156 Regulatory agencies for each country should also aim tow

157 has potential to assist food industries and regulatory agencies for food quality control, allowing d

158 ration, European Medicines Agency, and other regulatory agencies for indications beyond the kidney.

159 Monitoring of regulatory agencies for new drugs approvals ensures the

160 d by the FDA and is under review by European regulatory agencies for the adjuvant treatment of patien

161 The algorithm includes drugs approved by regulatory agencies for the treatment of PAH and/or drug

162 eous in the mid-term to consider a single EU regulatory agency for devices.

163 the Royal College of Surgeons, established a regulatory agency for training and certification of surg

164 vel therapeutic agents approved by the three regulatory agencies from 2001 through 2010 and determine

165 Regulatory agencies from the European Union, Unites Stat

166 ed Kingdom Medicines and Healthcare Products Regulatory Agency, from 1963 to 2024, were compiled usin

167 Regulatory agencies generally do not consider outcomes r

168 e reviewed international society guidelines, regulatory agency guidance documents, and standardized r

169 I were reported in accordance with Brazilian regulatory agency guidance.

170 ed data, the clinical research community and regulatory agencies have accepted the importance of a de

171 Recently, regulatory agencies have approved highly active biomarke

172 Regulatory agencies have begun incentivizing screening f

173 The medical community, the public, and even regulatory agencies have focused on specific preventable

174 Healthcare regulatory agencies have mandated a reduction in 30-day

175 Furthermore, given that regulatory agencies have recommended drugs be tested for

176 conclude that systems failures by oversight-regulatory agencies in communication to active clinician

177 Guidance documents from regulatory agencies in Europe and the United States have

178 Guidance documents from regulatory agencies in Europe and the United States have

179 inancial barriers, and discussed the role of regulatory agencies in facilitating research and impleme

180 ([(18)F]FES) is approved for clinical use by regulatory agencies in France and the United States.

181 al availability of new medicines approved by regulatory agencies in Germany and the US between Januar

182 ition to specifically assist researchers and regulatory agencies in interpreting the clinical importa

183 lthough ASPs are required institutionally by regulatory agencies in the United States and Canada, the

184 tes COVID-19 vaccine approvals at 3 medicine regulatory agencies in the US, EU, and Canada, character

185 cel-T and denosumab were approved in 2010 by regulatory agencies in the USA for men with metastatic C

186 phase 2 studies of new agents and may assist regulatory agencies in their evaluation and approval pro

187 It can contribute to the inspection by regulatory agencies, in addition to following the princi

188 that could prevent acceptance of results by regulatory agencies, including enrolment of heterogeneou

189 oponic production systems, and evaluation by regulatory agencies, including the CDC, FDA, and USDA, a

190 Nonanesthesiologists and governmental and regulatory agencies influence the delivery of sedation s

191 attempting clinical metabolic profiling, for regulatory agencies involved in the licensing of clinica

192 al following prior docetaxel and approval by regulatory agencies is anticipated.

193 cy and oversight of organ transplantation by regulatory agencies is of paramount importance to assure

194 , clinical trialists, industry sponsors, and regulatory agencies is vital to the development of stand

195 This path, also supported by regulatory agencies, is calling for an important change

196 om patients' groups, academia, industry, and regulatory agencies-is aimed at addressing this shortfal

197 dolescents decreased after U.S. and European regulatory agencies issued warnings about a possible sui

198 Stakeholders-including regulatory agencies, journal editors, clinical trial inv

199 ted from over 60 U.S. public health and food regulatory agency laboratories.

200 k in recently accumulated beebread was above regulatory agency levels of concern for acute or chronic

201 P1B1-mediated elimination and recognition by regulatory agencies, little is known about OATP1B3 regul

202 of vaccine stockpiles, increased support for regulatory agencies, maintenance and strengthening of li

203 ovals and discusses future ways sponsors and regulatory agencies may further enable development of th

204 al of these medications by the FDA and other regulatory agencies means that providers now have three

205 nce of the complimentary perspectives of the regulatory agency, medical examiners, physicians, and pi

206 mmunology (EAACI), experts from academia and regulatory agencies met with chamber operators to list t

207 the 14 UK Medicines and Healthcare products Regulatory Agency (MHRA) approvals reviewed by the Scott

208 by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for treating at-risk COVID-19 p

209 and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) have recently published documen

210 n from the Medicines and Healthcare products Regulatory Agency (MHRA) required a dossier summarising

211 regulations are less stringent; however, US regulatory agencies must act to ensure patient safety.

212 Such commercial activity suggests that regulatory agencies must better oversee this marketplace

213 Food safety regulatory agencies must consider both the exposure and

214 Scientific societies and regulatory agencies must ultimately establish standardiz

215 Industry and regulatory agencies need a consolidated and comprehensiv

216 Regulatory agencies need to ensure the safety and equity

217 lized mechanisms be licensed by the national regulatory agency (NRA) in the producing country, then p

218 This conclusion is in line with those of the regulatory agencies of US Food and Drug Administration,

219 ndings are timely given the renewed focus of regulatory agencies on reproductive safety.

220 in a timely manner is an essential goal for regulatory agencies, one which has particular importance

221 ing injustices, and (5) engagement with AIAN regulatory agencies or review boards.

222 shed in peer-reviewed journals, presented by regulatory agencies, or presented as conference abstract

223 urveyors from 16 oil and gas companies and 8 regulatory agencies participated, completing 488 tests o

224 Clinical researchers, regulatory agencies, payers, and the public embrace the

225 s paper describes current interactions among regulatory agencies, payers, sponsors, and investigators

226 The reports are used by regulatory agencies, private insurance providers, transp

227 ioprocessing to safe limits as stipulated by regulatory agencies, rather than trying to eliminate all

228 Many healthcare regulatory agencies recommend administering 'booster' do

229 Other regulatory agencies recommend assessing overall clinical

230 International regulatory agencies recommend testing drug therapy for p

231 Increased attention by the public and regulatory agencies regarding patient safety and quality

232 However, recommendations from regulatory agencies regarding the requirements for when

233 data were extracted from the ITCC database, regulatory agencies' registries, and publications.

234 Biopharmaceutical and regulatory agencies rely heavily on this technique for c

235 rs and clinicians; federal health officials; regulatory agency representatives; pharmaceutical, biote

236 for this interim analysis were collected per regulatory agencies' request as of June 30, 2017.

237 emic drugs in patients with type 2 diabetes, regulatory agencies require a comprehensive evaluation o

238 Regulatory agencies require comprehensive toxicity testi

239 Federal regulatory agencies require continuous verification of r

240 Therefore, clinicians, investigators, and regulatory agencies require improved understanding of th

241 armaceutical and biotechnology companies and regulatory agencies require novel methods to determine t

242 When regulatory agencies require pharmaceutical and device ma

243 of plasma derivative drug manufacturers and regulatory agencies responsible for the safety testing a

244 mented a series of open-source LLMs within a regulatory agency's local network and assessed their per

245 itoring criteria, there are more options for regulatory agencies seeking to protect beachgoers from w

246 e societal impact of mental disorders, while regulatory agencies should adopt more flexible and bioma

247 The guidance issued by regulatory agencies should be carefully considered to en

248 Regulatory agencies should collaboratively develop proce

249 monitoring and emissions reporting and that regulatory agencies should consider cumulative environme

250 Payers and regulatory agencies should risk-adjust hospital cost ass

251 Researchers and regulatory agencies should work together to determine wh

252 he US Food and Drug Administration and other regulatory agencies since 2008.

253 nd hallucinations) and have been approved by regulatory agencies since the 1950s.

254 mendations from MAQC-II should be useful for regulatory agencies, study committees and independent in

255 Regulatory agencies such as EFSA and JECFA have establis

256 Global experts from academia, regulatory agencies such as the Food and Drug Administra

257 Cancer medicines are approved by regulatory agencies, such as the US Food and Drug Admini

258 Despite calls for TGC by various experts and regulatory agencies, supporting data remain somewhat inc

259 ive and balanced system, the use of existing regulatory agencies that oversee solid organs should pro

260 There is increasing recognition from regulatory agencies that racial and ethnic representatio

261 In the absence of drugs approved by regulatory agencies, the current standard of care remain

262 several DASS are internationally accepted by regulatory agencies, the data interpretation procedures

263 osteonecrosis were disseminated by national regulatory agencies, the manufacturers of bisphosphonate

264 structure; and perspectives from clinicians, regulatory agencies, the pharmaceutical industry, and pa

265 The 2 largest regulatory agencies, the US Food and Drug Administration

266 Despite guidelines for testing from regulatory agencies, these interactions are usually disc

267 increased the urgency of health systems and regulatory agencies to address longstanding health dispa

268 provide science-based information desired by regulatory agencies to address public concerns about the

269 e pharmaceutical sector, 2) partnership with regulatory agencies to arrive at meaningful outcomes for

270 ll, public concern motivated the company and regulatory agencies to commission several research studi

271 th stakeholders from academia, industry, and regulatory agencies to discuss the challenges and strate

272 opment of new products, quality control, and regulatory agencies to ensure compliance with cocoa prod

273 ake recommendations for transplant teams and regulatory agencies to ensure fair access to transplant

274 ologies (NAMs) is encouraging industries and regulatory agencies to evaluate novel assays.

275 rmaceutical and biotechnology companies, and regulatory agencies to facilitate the development of new

276 s stakeholders in the agriculture sector and regulatory agencies to focus risk management efforts on

277 urdened with legacy instruments, mandates by regulatory agencies to include the patients' perspective

278 rge scientific journals, peer reviewers, and regulatory agencies to require researchers to consider S

279 , it is essential for authors, journals, and regulatory agencies to specify the carbapenemases meant.

280 pixaban) have been approved by international regulatory agencies to treat atrial fibrillation and ven

281 It is valuable for patients, clinicians, and regulatory agencies to understand how to best assess CKD

282 one set of such institutions-the courts and regulatory agencies-to see how well EJ claims have fared

283 Medicines and Healthcare products Regulatory Agency, UK Health Security Agency, Bill & Mel

284 an Medicines Agency, European medical device regulatory agencies, US Food and Drug Administration, as

285 form near-term technology decisions at state regulatory agencies, utilities, and pipeline companies,

286 To supplement oversight by national regulatory agencies, we recommend expansion of the role

287 pe 1 diabetes submitted to U.S. and European regulatory agencies, we recommend use of our definition.

288 -databases of planned and ongoing trials-and regulatory agency websites such as the European Medicine

289 f Science, Embase, CINAHL, PsycINFO, LiLACS, regulatory agencies' websites, and international registe

290 % loads calculated by methodology adopted by regulatory agencies were found to underestimate PM(2.5)

291 The software targets the needs of regulatory agencies, where AUC plays a critical role in

292 than the corresponding emissions reported to regulatory agencies, while measurement-derived landfill

293 move into the 21st century, professional and regulatory agencies will be seeking to expand process me

294 ance in clinical trials and its reporting to regulatory agencies will facilitate an improved understa

295 otherapy studies and immunogenicity testing, regulatory agencies will progressively increasingly dema

296 authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses

297 l sweeteners daily that are declared safe by regulatory agencies without evaluation of their potentia

298 agencies and donors, vaccine manufacturers, regulatory agencies, World Health Organization (WHO) and

299 Regulatory agencies worldwide have enhanced warnings or