ライフサイエンスコーパス: approval

1 otentially applicable for regulatory product approval.

2 complex postprocessing, or lack of clinical approval.

3 y still await clinical validation and formal approval.

4 clerosis (MS) have recently gained marketing approval.

5 rom electronic medical records after ethical approval.

6 time of about six years from IND receipt to approval.

7 ies might remain incomplete many years after approval.

8 ch tests are normally subjected prior to FDA approval.

9 ntibiotics or evaluating new antibiotics for approval.

10 veral oligonucleotide drugs recently gaining approval.

11 gy has, however, not been met with universal approval.

12 was exempted from institutional review board approval.

13 cacy and potentially accelerating regulatory approval.

14 h, and regulatory process for NDA filing and approval.

15 irst 2 years of Food and Drug Administration approval.

16 ill under investigation or awaiting clinical approval.

17 atric clinical trials and seeking regulatory approval.

18 cal trials and recommended by industry after approval.

19 d in the setting of clinical trials and drug approval.

20 nd without PTSD from a single site under IRB approval.

21 15 days between initial visit and insurance approval.

22 e increasingly available at the time of drug approval.

23 fore most of these drugs received regulatory approval.

24 complete response rates, supporting the FDA approval.

25 s why vaccines fail to advance to regulatory approval.

26 of their recommendations regarding treatment approval.

27 ted or obtained Food and Drug Administration approval.

28 t the use of ISBCS (16.0%); and (4) hospital approval (13.3%).

29 nd its predecessors [1984-2018], Accelerated Approval [1992-2018], and Breakthrough Therapy [2012-201

30 ) College approval (20.5%); (2) medico-legal approval (20.2%); (3) evidence to support the use of ISB

31 acted as barriers were lack of: (1) College approval (20.5%); (2) medico-legal approval (20.2%); (3)

32 well-curated validation datasets, regulatory approval and fair reimbursement strategies.

33 pharmaceuticals (NEPs) submitted for market approval and in clinical application today.

34 Institutional review board approval and informed patient consent were obtained.

35 al liver toxicity is required for regulatory approval and is an expensive and time-consuming process.

36 therapies have recently achieved conditional approval and many more are at advanced stages of clinica

37 s the goal; however, new paths to regulatory approval and mass-market distribution, distinct from tho

38 Regulatory approval and normative guidance, now for almost 70 count

39 To date, five ADCs have received market approval and over 100 are being investigated in various

40 Over the last 4 decades, the approval and regulation processes for pharmaceutical age

41 9.2% (14/48) reported using pre-prescription approval and/or prospective audit and feedback to target

42 re surveyed on their use of pre-prescription approval and/or prospective audit and feedback to target

43 scovery strategy, as evidenced by recent FDA approvals and clinical trials.

44 arize clinical trials leading to recent drug approvals and discuss optimal treatment selection.

45 therapeutic agents that received accelerated approval, and products approved between 2014 and 2018.

46 he evidence, US Food and Drug Administration approvals, and consensus when evidence was lacking.

47 ns unanswered at the time of drug and device approval are resolved in a timely fashion during the pos

48 These approvals are also anticipated to herald the emergence o

49 e a great impact in medicine, and regulatory approvals are starting to be achieved for nanomedicines

50 Food and Drug Administration approval as a qualitative diagnostic test for measles, m

51 The compound has received additional FDA approval as first-line therapy with improvement in progr

52 Administration and/or Conformite Europeenne approval (as of November 2019).

53 initiatives have substantially changed drug approval at the FDA.

54 Regulatory approvals based on large-cohort trials with surrogate or

55 cancer trials submitted to support FDA drug approval between January, 2008, and December, 2017.

56 e a scientific study validity and a stamp of approval but also has substantially shaped how we collec

57 rrogate endpoints for accelerated regulatory approval, but EFA as a surrogate endpoint requires furth

58 red likelihood of living donor screening and approval by participation in the LDN program.

59 h an oral regimen is recommended or, pending approval by regulatory bodies and availability, with a l

60 weeks for treatment or every 8 weeks pending approval by regulatory bodies and availability.

61 Following approval by the ethics committee, a long-term supplement

62 Following approval by the European Commission (2011), steviol glyc

63 The current challenges of gaining clinical approval by the FDA-in particular, with regards to biolo

64 and second-line therapies, and are awaiting approval by the Food and Drug Administration or have bee

65 en reported, but none has been validated for approval by the Food and Drug Administration.

66 ited in three consecutive groups, subject to approval by the independent safety monitoring committee.

67 ing has increased rapidly since simultaneous approval by the U.S. Food and Drug Administration and Ce

68 arly success in the clinic, which has led to approval by the US Food and Drug Administration of multi

69 ed States Food and Drug Administration (FDA) approval can be a slow and difficult process.

70 Following ethical approval, children (<=16 years) undergoing appendicectom

71 been evaluated in 2 randomized trials; post-approval clinical data are limited.

72 With Research Ethics Board approval, clinical data obtained from the charts include

73 the 1.3 noninferiority margin for regulatory approval, conducting trials for longer durations, consid

74 s new therapeutic agents are tested and post-approval data become available, the regulatory framework

75 nant and nonmalignant cells receive clinical approval each year from the FDA.

76 In 2019, post-approval evaluation of anti-CD19 CAR T-cell therapy in p

77 ed to obtain US Food and Drug Administration approval excluded bicuspid anatomy.

78 that led to US Food and Drug Administration approval excluded patients with central nervous system (

79 Use of Accelerated Approval, Fast-Track, and Priority Review for new drugs

80 Initial approval for 53 (93%) of the vaccines was supported by r

81 ia uptake, and toxicology to seek regulatory approval for a first-in-human study.

82 nostic US Food and Drug Administration (FDA) approval for adult and pediatric patients with Trk-drive

83 ive HDAC inhibitors have received regulatory approval for cancer chemotherapy while many others are i

84 the CCR5 inhibitor maraviroc (MVC), despite approval for clinical use, have not yet been well evalua

85 his compound family, ixabepilone, made it to approval for clinical use.

86 and in patients or that have received recent approval for clinical use.

87 have few impediments in obtaining regulatory approval for commercial use if similar effects were foun

88 ikely gain U.S. Food and Drug Administration approval for commercialization in the near future.

89 cers, and many have also achieved regulatory approval for early clinical settings as adjuvant therapi

90 udy resulted in the FDA granting accelerated approval for enfortumab vedotin in December 2019 for pat

91 Importantly, sPIF received a FDA Fast Track Approval for first in human trial in autommuninty (compl

92 l, a long way should be paved to achieve FDA approval for most of the proposed products.

93 ess to naloxone, possibly through regulatory approval for over-the-counter sales.

94 Nephrologist approval for placement could not be determined, and 2.7%

95 Recent and anticipated regulatory approval for products targeting acute lymphoblastic leuk

96 Approval for rapid expanded access to the recombinant ve

97 propriate national research ethics committee approval for the countries where the study was conducted

98 The FDA recently granted tissue-agnostic approval for the first-in-class TRK inhibitor larotrecti

99 r, no systemic therapy has gained regulatory approval for the specific treatment of BCBM and this rem

100 as Hsp90 inhibitors progress toward clinical approval for the treatment of cancer.

101 rectinib and pembrolizumab have received FDA approval for the treatment of patients with tumours harb

102 h in November 2018 received the first global approval for the treatment of pediatric and adult patien

103 unorubicin that recently received regulatory approval for the treatment of therapy-related acute myel

104 Yet, even with the current FDA approval for two FLT3 inhibitors, these modalities were

105 Although 7-T MRI has recently received approval for use in clinical patient care, there are dis

106 along with treatment advances - particularly approvals for and use of targeted therapies - is likely

107 ive to immunotherapy, as shown by regulatory approvals for immune checkpoint inhibitors.

108 Since its approval, for the following 10 years, sorafenib remained

109 The process begins with approval from ASCO's Clinical Practice Guideline Committ

110 ousehold surveys were collected monthly with approval from Ghana Health Services.

111 After receiving approval from the clinical studies Ethics Committee, mag

112 logy of the Dental Institute after obtaining approval from the Ethical Committee.

113 eron gamma release assays (IGRAs) to receive approval from the U.S. FDA, replacing its predecessor, Q

114 Nine ADCs have received approval from the US Food and Drug Administration and mo

115 In May 2019, tafamidis received expedited approval from the US Food and Drug Administration as a b

116 Eltrombopag (EPAG) received approval from the US Food and Drug Administration for th

117 With approvals from the Federal Select Agent Program and the

118 rom the authorization of clinical testing to approval has remained at approximately 8 years over that

119 The number of immunotherapy drug approvals has been increasing, with numerous treatments

120 at a drug will eventually receive regulatory approval, has been notoriously hard given the complexiti

121 However, several FDA approvals have occurred in the past 4 years, restoring h

122 -small-cell lung cancers; histology-agnostic approvals have yet to be granted.

123 Recent medication approvals highlight why and how the distribution of clin

124 A approved combination drugs, from the first approval in 1943 through 2018.

125 dorsed refusal in 110 of 155 cases (71%) and approval in 45 (29%), based on clinical criteria.

126 is the first epigenetic therapy to gain FDA approval in a solid tumor.

127 Since its approval in April 2018, osimertinib has been widely adop

128 treatment options at the time of regulatory approval in Europe and the USA.

129 kinase inhibitor, which was granted full FDA approval in March 2017 based on targeting EGFR T790M res

130 neration antipsychotics receiving regulatory approval in the 1990s.

131 specific immunotherapeutic drugs have gained approval in the past several years, demonstrating immuno

132 ation technique that has received regulatory approval in the United States.

133 ave the way for Food and Drug Administration approval in the United States.

134 acteriophages (phages) continue to lack drug approval in Western medicine, an increasing number of pa

135 ly phase trials, sometimes resulting in drug approvals in the absence of large-scale trials.

136 The success rates for new drug approvals in the United States are < 15%, and investment

137 s, with over 40% of INDs obtaining marketing approval, in a median time of about six years from IND r

138 Currently accepted endpoints for conditional approval include resolution of NASH without worsening of

139 The mean annual number of new drug approvals, including biologics, was 34 from 1990-1999, 2

140 New biologic product approvals increased from a median of 2.5 from 1990-1999,

141 trial and another that recently garnerd FDA-approval, indicating a bright future for targeted small

142 Patient access to a drug after US regulatory approval is controlled by complex interactions between g

143 accumulate in adipose tissue, and regulatory approval is not being sought.

144 ucture, combination composition, and year of approval is presented as well as the top 24 most commonl

145 nistration (FDA) for r/r ALL (CD19CAR T-cell approval is restricted to patients <=25 years old).

146 US Food and Drug Administration/CE clinical approval, it can be a clinically feasible biomarker that

147 Furthermore, conditional on approval, lenders, on average, charge about 0.02-0.2% hi

148 ission rates have been much higher than type approval limit values for all manufacturers, but some pe

149 These approvals marked a major milestone in the field of cell

150 Accelerated approvals may fail to expedite drugs to market in this s

151 hanges occurred within four to nine years of approval (median: six years).

152 gued that the current process for regulatory approval needs to generate more evidence that is useful

153 on (NDA) process that ultimately resulted in approval of (68)Ga-DOTATOC in August 2019.

154 an provide required data for translation and approval of (99m)Tc-PSMA I&S by regulatory agencies.

155 have led to US Food and Drug Administration approval of 2 anti-programmed cell death 1 antibodies (p

156 With the recent approval of 2 NIRAF-based devices for label-free identif

157 ions currently in the market, and the recent approval of 3 key nanomedicine products (e.

158 en developed, which has culminated in recent approval of a budesonide effervescent tablet in Europe;

159 t 12-18 months, and the typical timeline for approval of a new antiviral therapeutic agent can exceed

160 d help in developing and securing regulatory approval of a new macrolide/ketolide that is active agai

161 The recent development and regulatory approval of a variety of serological assays indicating t

162 have led to US Food and Drug Administration approval of adult dosing down to 20 kg.

163 ntrolled studies will be required before the approval of AI techniques by the health authorities.

164 The approval of an antisense oligonucleotide therapy for SMA

165 untermeasure research resulted in the recent approval of an EBOV-targeted vaccine by European and US

166 eans of treating SMA and recently led to FDA approval of an intrathecally delivered SMN-enhancing oli

167 came more than 2 years after the FDA's first approval of an SGLT2 inhibitor, although the phenomenon

168 ter-phase (II and III) trials supporting FDA approval of anticancer drugs from 1998 to 2018 were eval

169 of pneumonic cases of disease, we sought FDA approval of antimicrobials for treatment under the Anima

170 te, these results have not led to regulatory approval of any of these drugs for a HF indication or a

171 verall, the database is insufficient for FDA approval of any psychedelic compound for routine clinica

172 The approval of bedaquiline (BDQ) for the treatment of tuber

173 rituximab in open-label clinical trials, the approval of belimumab (which blocks B cell-activating fa

174 FDA approval of belimumab in 2011 was the first successful S

175 Almost a decade has passed since the approval of belimumab, an mAb directed against B lymphoc

176 (2009), and in the USA (2015), to facilitate approval of biological drugs that are highly similar to

177 With the approval of CD19-targeted chimeric antigen receptor (CAR

178 ave enabled the rapid review and accelerated approval of certain drugs in the absence of survival dat

179 rm multicenter study designed for regulatory approval of coronary IVL.

180 The development and approval of cyclin-dependent kinase (CDK) 4 and 6 inhibi

181 sults led to US Food and Drug Administration approval of dabrafenib plus trametinib as adjuvant treat

182 Following the approval of delamanid and pretomanid as new drugs to tre

183 een rigorous testing and the need for timely approval of drugs that have benefits that outweigh their

184 pid advancement in the field has resulted in approval of edge-to-edge mitral valve repair with the Mi

185 The development and approval of engineered cellular therapies are revolution

186 inhibitors have so far led to the regulatory approval of four PARP inhibitors for the treatment of se

187 d Health Organization recommendation and the approval of funding from Gavi, the Vaccine Alliance (Gav

188 ported the U.S. Food and Drug Administration approval of gadobutrol-enhanced CMR (0.1 mmol/kg) to ass

189 gene delivery vehicles, especially after the approval of Glybera in Europe and Luxturna in the United

190 y pathway has been created to facilitate the approval of histology-agnostic indications.

191 psed patients with CLL, provided support for approval of ibrutinib in the United States and Europe.

192 ry properties of type I IFNs have led to the approval of IFN-beta for the treatment of relapsing-remi

193 in the past decade with the development and approval of immune checkpoint inhibitors targeting progr

194 and a necessary criterion for the regulatory approval of instruments for implant hygiene.

195 o the biology of antidepressants and the FDA approval of its s-isomer, Esketamine (Spravato), the fir

196 alysis set includes the 55 patients on which approval of larotrectinib was based.

197 allow future development and FDA regulatory approval of modernized AST to guide treatment.

198 The approval of moxidectin in 2018 and triclabendazole in 20

199 h lays the groundwork for the clinical trial approval of Nell-1.

200 omized controlled trials (RCTs) are used for approval of new antibiotics and making changes to antibi

201 problems that has slowed the development and approval of new anticancer therapies is the lack of prec

202 ries of review personnel responsible for the approval of new drugs.

203 dered the most appropriate criterion for the approval of new HBV assays to determine efficacy endpoin

204 are of long-acting insulins before and after approval of new insulin products and to estimate savings

205 sk that poses a major challenge, both to the approval of new medicines and devices by regulatory auth

206 In spite of the recent approval of new promising targeted therapies, the clinic

207 ort clinical decision making, as well as the approval of new therapeutics by healthcare authorities.

208 clinical trials that resulted in regulatory approval of nivolumab and the combination of ipilimumab

209 pharmaceutical market, such as accelerating approval of non-first-in-class drugs, will likely not re

210 es from initial regulatory submission before approval of oncology biosimilars were 1.5 years (EMA), 1

211 n of pan-genotypic regimens; and accelerated approval of paediatric formulations.

212 This led to the approval of pembrolizumab adjuvant treatment by the Euro

213 Despite the tissue-agnostic approval of pembrolizumab in mismatch repair deficient (

214 Despite scientists' strong approval of science communication efforts, potential are

215 However, recent approval of several new agents has transformed treatment

216 rious BRCA1/2 mutations, leading to clinical approval of several PARPis.

217 With the recent FDA approval of several RPT agents, the remarkable potential

218 over time that corresponded to the timing of approval of targeted therapy.

219 The development and ultimate approval of tecovirimat for the antiviral treatment of s

220 This suggests possible approval of the biosensors for POC development.

221 The recent approval of the CFTR potentiator drug ivacaftor (Vx-770)

222 describe the clinical trials that led to the approval of the first immunotherapeutic agents for HNSCC

223 Approval of the first siRNA treatments in humans has ope

224 findings into clinical trials and, moreover, approval of the first therapies for blinding inherited a

225 The approval of the multikinase/KIT inhibitor midostaurin ha

226 Since the approval of the oral factor Xa inhibitors, there have be

227 Moreover, the recent approval of the radiolabeled somatostatin analog (177)Lu

228 These data could contribute to the approval of the subcutaneous daratumumab formulation by

229 After obtaining the approval of the Veneto Regional Authority's Bioethical C

230 s, data from clinical trials have led to the approval of the XPO1 inhibitor selinexor (plus dexametha

231 Although regulatory approval of this approach is still pending, preparing th

232 ell therapy directed to CD19 have led to the approval of this therapy by the FDA and the European Med

233 (AI), given US Food and Drug Administration approval of three agents in this class.

234 Despite the recent approval of tolvaptan, safer and more effective alternat

235 nduced parkinsonism, and treatment, with the approval of valbenazine and deutetrabenazine, the first

236 These trials resulted in rapid FDA approvals of anti-CD19 CAR T cell products for both ALL

237 nd the first US Food and Drug Administration approvals of cell therapies for the treatment of cancer.

238 Subsequent data led to approvals of combination strategies of immune checkpoint

239 de therapeutics and provide an update on FDA approvals of oligonucleotides from 2017 until the second

240 S.Food and Drug Administration (FDA) for new approvals of opioid analgesics.

241 With the landmark approvals of pembrolizumab for the treatment of patients

242 The FDA approvals of Rhopressa, Vyzulta, and Roclatan for glauco

243 oncology, especially with recent regulatory approvals of rituximab, trastuzumab, and bevacizumab bio

244 e on drugs and devices at the time of market approval often persist in the post-marketing period.

245 iators are in clinical trials, with possible approval on the horizon.

246 f programmes that facilitate drug and device approvals on the basis of incomplete benefit and harm da

247 Hospitals often use pre-prescription approval or prospective audit and feedback to target flu

248 The traditional regulatory drug approval paradigm comprising discrete phases of clinical

249 After institutional review board approval, participants were enrolled prospectively from

250 Biosimilar regulatory approval pathways were authorised in the EU (2006), in J

251 hundreds in the final stages of the clinical approval pipeline, there is not a single gene therapy ap

252 e-lowering therapies were granted regulatory approval primarily from smaller studies that have demons

253 There were few FDA approvals prior to 2016, mostly of drugs that eventually

254 ucational needs would improve the regulatory approval process and market launches for these biologics

255 Pre- and post-CQIT implementation metrics of approval process efficiency and patient safety data were

256 f the treatment and trial design in the drug approval process to reduce financial and logistical cost

257 structured, arcane, but rigorous regulatory approval process.

258 eries and the lack of appropriate regulatory approval processes at the time of the premarket clearanc

259 ormation related to vaccine-related science, approval processes, and the development of clinical reco

260 accines (1998-2018); special development and approval programs (Orphan drug [1984-2018], Fast-Track [

261 ents receive exception points at a universal approval rate allowing prompt access to deceased donor L

262 omparable different-sex loan applicants, the approval rate for same-sex applicants is ~3-8% lower.

263 en July 2015 and August 2018 represent a 97% approval rate from insurance, with 28% of prescriptions

264 tiated between 2000 and 2009, we find IND-to-approval rates reduced to 23% with median development ti

265 ance, with U.S. Food and Drug Administration approval recently being obtained for theranostic agents

266 was 10.0% (95% CI, 2.6% to 16.9%), with most approvals representing H1N1 or H5N1 vaccines.

267 to 52.8% in 2015-2017, based on 124 and 106 approvals, respectively, while the median number of pati

268 nase inhibitors have been granted regulatory approval, specifically for the treatment of ROS1 fusion-

269 nimod, another S1P receptor modulator in the approval stage that also targets S1PR1 and S1PR5, reduce

270 ment of therapies for rare diseases, such as approval statistics, engagement of patients in the proce

271 generation plans, ensuring that future post-approval studies address any limitations of the data ava

272 s a prospective multicenter, single-arm post-approval study conducted at 15 hospitals in 9 countries.

273 d effectiveness has been monitored in a Post Approval Study.

274 ly from the Argus II Retinal Prosthesis Post-Approval study.

275 The proportion of new approvals supported by at least 2 pivotal trials decreas

276 ndings confirm the robustness of the vaccine approval system and postmarketing surveillance.

277 that led to US Food and Drug Administration approval, the first ever for BPDCN.

278 Rationale: Since their approval, there has been no real-world or randomized tri

279 ndustry champions to bring them to marketing approval, there may be justification for a more concerte

280 With institutional review board approval, this study retrospectively compared 40 consecu

281 delays in gaining Institutional Review Board approval, timeliness of budget and contractual negotiati

282 Ethical approval to conduct the study was obtained from relevant

283 US law requires testing of new drugs before approval to ensure that they provide a well-defined bene

284 isease-modifying medications with regulatory approval to treat multiple sclerosis (MS) are unable to

285 All endometriosis drug approvals to date have been contraceptive, limiting thei

286 The initial approval trial characteristics were similar in vaccines

287 as performed with institutional review board approval using data collected from diabetic patients tre

288 The average timeline from phase 2 to approval was 4.4 years (range, 6.4 weeks to 13.9 years).

289 titute for Health and Care Excellence (NICE) approval was based on efficacy data, but the final appra

290 itive, negative, or neutral toward treatment approval was extracted in a blinded fashion using a pilo

291 Institutional review board approval was obtained for this Health Insurance Portabil

292 rials and Methods Institutional review board approval was obtained for this HIPAA-compliant observati

293 Institutional review board approval was obtained for this prospective study (clinic

294 Institutional review board (IRB) approval was obtained for this retrospective study to tr

295 Ethical approval was obtained to recruit, following informed wri

296 Ethical approval was obtained.

297 With institutional IRB approval, we examined a subset of our mechanically venti

298 s past US Food and Drug Administration (FDA) approvals were not based on clinical trials that meet to

299 trials needed for regulatory evaluation and approvals, which generally must demonstrate noninferiori

300 Only 15% of drugs advance from Phase II to approval, with ineffective targets accounting for over 5