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1 FDA guidance for regulation of this procedure is in flux
2 FDA microscopy was positive for a median of 119 (interqu
3 FDA microscopy-negative bacteria in these pretreatment s
4 FDA-approved mineralocorticoid receptor (MR) antagonists
5 med a large-scale screen of a library of 107 FDA-approved compounds to identify hits that prevented t
6 proximately 21,000 compounds), including 108 FDA-approved and 70 clinical trial drugs as well as geno
7 , we addressed this challenge by testing 128 FDA-approved or investigational drugs as either single a
8 erformance of 4 PD-L1 platforms, including 2 FDA-cleared assays, 1 test for investigational use only,
9 (1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the
12 to other drugs, we conducted a screen of 446 FDA approved drugs using two Dck-defective BXH-2 derived
17 can receive US Food and Drug Administration (FDA) accelerated approval based on showing an effect in
19 rived from the Food and Drug Administration (FDA) Adverse Event Reporting System and meaningfully cov
20 oved by the US Food and Drug Administration (FDA) and required pharmacogenomic biomarker testing, we
21 oved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) between 200
22 r 2017, the US Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (GO) for the treatme
24 ed by the U.S. Food and Drug Administration (FDA) as a stroke prevention alternative to warfarin for
25 within the US Food and Drug Administration (FDA) average bioequivalence (ABE) acceptance criteria of
26 ling, the U.S. Food and Drug Administration (FDA) banned CPC from certain products and requested more
27 ed by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline
28 ed with the US Food and Drug Administration (FDA) detect programmed cell death ligand 1 (PD-L1) to en
31 y (EMA) and US Food and Drug Administration (FDA) guidance for adults was used in paediatrics, and wh
32 ording to U.S. Food and Drug Administration (FDA) guidelines, which included demonstrating the effect
35 approved by US Food and Drug Administration (FDA) in late 2016 and several other compounds are in adv
36 within the US Food and Drug Administration (FDA) is tracking the use of nanotechnology in drug produ
37 s receiving US Food and Drug Administration (FDA) licensure 2005-2012 inclusive in seven neurological
41 United States Food and Drug Administration (FDA) the authority to ensure the safety of chemicals in
42 oved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) s
43 oved by the US Food and Drug Administration (FDA), and to examine whether any novel therapeutic chara
44 ses how the US Food and Drug Administration (FDA), the United States Pharmacopeial Convention (USP) a
46 effects of the Food and Drug Administration (FDA)-approved anti-helminth drug nitazoxanide (NTZ) on m
47 rary of 106 US Food and Drug Administration (FDA)-approved anticancer drugs or compounds currently in
48 w doses of the Food and Drug Administration (FDA)-approved compound Tacrolimus, blocks calcineurin's
49 pirfenidone, a Food and Drug Administration (FDA)-approved drug for idiopathic pulmonary fibrosis, fo
50 pose ACF, a US Food and Drug Administration (FDA)-approved drug for nononcological use in humans, as
51 ermore, the US Food and Drug Administration (FDA)-approved drug pyrvinium delays and/or inhibits dise
52 oximately 34%) Food and Drug Administration (FDA)-approved drugs and account for a global sales volum
53 own targets of Food and Drug Administration (FDA)-approved drugs and it too proves to be highly effec
55 ng zolpidem, a Food and Drug Administration (FDA)-approved GABA-positive allosteric modulator, during
58 here are no US Food and Drug Administration (FDA)-approved T cell therapeutics on the market, and FDA
62 ns tested positive for stx by an alternative FDA-cleared nucleic acid amplification test (NAAT) but w
65 a (TSPO) via a combination of disulfiram, an FDA approved drug for alcoholism, and (64)CuCl2 (termed
66 potent radiosensitizer, and gemcitabine - an FDA approved chemotherapeutic drug for lung cancer chemo
72 ection that evaluated at least 8 weeks of an FDA-approved interferon-free HCV regimen that included a
73 ancer subjects who received sipuleucel-T, an FDA-approved immunotherapy, we were able to detect chang
77 rcadian waveform, first derivative analysis (FDA), revealed internal phase patterning to the circadia
80 paediatric clinical trials and adult EMA and FDA guidance highlighted that regulatory definitions are
81 roved T cell therapeutics on the market, and FDA regulations are only slowly adapting to the new tech
82 association between ODAC recommendations and FDA approval was observed for members with FCOIs with th
83 Here we screened in an unbiased approach FDA-approved compounds with respect to Angpt-2 suppressi
84 ODAC recommendations and final FDA approval; FDA approval was received for all 41 drugs that ODAC rec
85 fold higher) binding affinity than approved FDA tracers, while also indicating binding to high affin
90 -co-glycolic acid) (PLGA) is a biodegradable FDA approved polymer and widely used in drug and vaccine
94 mber of injectable hydrogels are approved by FDA as surgery sealants, tissue adhesives, and are now b
99 n by regulatory agencies, including the CDC, FDA, and USDA, augur well for advancing this novel conce
100 ized by whole-genome sequencing from the CDC-FDA Antibiotic Resistance Isolate Bank were evaluated, i
101 ening (HTS) assay to screen and characterize FDA-approved, off-patent library drugs for anti-Mycobact
106 ms is demonstrated using a naturally derived FDA approved material (beeswax) as the drug carrier and
107 putum microscopy with fluorescein diacetate (FDA, evaluating M. tuberculosis metabolic activity) for
108 The goal of this workshop was to discuss FDA approval requirements and the expectations for appro
109 sources, and the overlap between DrugCentral FDA-approved drugs and their presence in four different
110 dary outcomes from ClinicalTrials.gov, Drugs@FDA mentioned 1061 (55%) and included results data for 3
111 een the rapid identification of an effective FDA-approved therapy, and the collateral benefits have i
113 The recent emergence of three effective FDA-approved proteasome-inhibiting drugs, bortezomib (Ve
114 gically modulated in vitro using an existing FDA-approved drug, Nitazoxanide, suggesting a possible a
118 applied in the radiosynthesis of 5'-[(18) F]FDA, with overall radiochemical conversion (RCC) more th
119 ement between ODAC recommendations and final FDA approval; FDA approval was received for all 41 drugs
120 ciety, which discussed consensus methods for FDA-directed human testing and approval of investigation
123 all linear combinations of ring systems from FDA approved drugs, up to three rings in length and up t
124 ce the effectiveness of the first-generation FDA-approved integrase strand transfer inhibitors (INSTI
126 at KCNQ-type K(+) channel openers, including FDA-approved drug retigabine (ezogabine), show antidepre
127 ptima HIV-1 Quant Dx assay (Aptima assay) is FDA cleared for blood plasma HIV-1 RNA quantitation.
130 ymphedema treatment as topical tacrolimus is FDA-approved for other chronic skin conditions and has a
132 t cancers (TNBC) are highly aggressive, lack FDA-approved targeted therapies, and frequently recur, m
133 ufficient to explain the superiority of many FDA-approved drug combinations in the absence of drug sy
134 eir Hb after 42 days of storage, the maximum FDA-approved length of time for the cold storage of RBCs
135 contacts of patients with higher than median FDA microscopy results (crude hazard ratio [HR], 3.8; P
141 es with high mortality and morbidity, and no FDA-approved vaccines or therapies are currently availab
142 g insult remain ill-defined and there are no FDA approved pharmaceutical agents or medical countermea
145 y of RAS-directed therapeutics, there are no FDA-approved drugs that are broadly effective against RA
148 use disease worldwide for which there are no FDA-licensed vaccines, effective postexposure prophylact
152 d Bunyavirus families, for which there is no FDA-approved vaccine or therapeutic available, with the
156 By screening the NIH clinical collections of FDA-approved drugs, we identified tacrolimus (FK-506) as
157 ents with lower than median concentration of FDA microscopy-positive M. tuberculosis, 10% of their co
158 ar evidence and therapeutic effectiveness of FDA-approved ALK inhibitors indicated that EML4-ALK is a
159 ly lays emphasis on biological evaluation of FDA approved photosensitizing agents as well as newly de
162 therapeutic activity of over 5,000 pairs of FDA-approved cancer drugs against a panel of 60 well-cha
163 med a moderate throughput chemical screen of FDA-approved drugs and natural compounds, and found that
164 LT-scanner to identify the known targets of FDA-approved kinase inhibitors based on templates involv
167 apeutic characteristics known at the time of FDA approval, including drug class, therapeutic area, pr
169 inhibitor to overcome the resistance of one FDA approved, widely used chemotherapeutic paclitaxel, m
170 tent Parathyroid Hormone (I-PTH) is the only FDA approved anabolic drug therapy available for the tre
171 either the FEMA "High Priority Chemicals" or FDA Harmful and Potentially Harmful Constituents lists w
173 xperienced operators, in the real-world post-FDA approval experience of LAAC, procedural success was
174 can be used as an approach for prioritizing FDA-approved drugs with repurposing potential, which cou
176 using effectiveness data from publications, FDA guidance, and our experience in reviewing publicatio
178 mivirsen and mipomersen, which have received FDA approval to treat cytomegalovirus retinitis and high
180 tor venetoclax (Venclexta) recently received FDA approval for the treatment of a specific subset of p
181 The Xpert MRSA NxG assay recently received FDA clearance for the direct detection of MRSA from nasa
182 uman antibody targeting CTLA-4 that received FDA approval for the treatment of metastatic melanoma in
183 against T2DM has been invigorated by recent FDA approval of Symlin, which is a large conformationall
184 cells has accelerated, leading to the recent FDA approval of several drugs that reduce cancer progres
186 formed a clinical evaluation of the recently FDA-cleared illumigene HSV 1&2 loop-mediated isothermal
187 ulti-drug resistant TB (MDR-TB), repurposing FDA (U.S. Food and Drug Administration) -approved drugs
188 , end point status, and significant results; FDA reviewer feedback on PRO end points; and study desig
190 c pH and cis-diols (such as mannitol, a safe FDA approved drug for diuresis) through particle size me
191 a chemical compound, we predicted that seven FDA-approved drugs can be repurposed as novel anti-cance
195 One thousand seven hundred and sixty-six FDA-approved drugs and 259 experimental drugs were scree
198 data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA s
218 eptide (RK-10-Biotin) was tested against the FDA-approved SP263 clone on biopsied patient tissues.
221 ed for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case
223 highlights important differences between the FDA- and EMA-approved dose recommendations and informs t
224 new active cancer molecules approved by the FDA and EMA between 2003 and 2013, 53 were appraised by
225 k, or High risk) established recently by the FDA and major stakeholders in the Drug Discovery field f
226 biological mesh devices were approved by the FDA based on substantial equivalence to a group of nonbi
228 dy of all novel therapeutics approved by the FDA between January 1, 2001, and December 31, 2010, foll
230 Nanoliposomal irinotecan is approved by the FDA for gemcitabine-refractory metastatic pancreatic can
233 Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postm
234 ications granted accelerated approval by the FDA in 2009-2013, efficacy was often confirmed in postap
235 aboratory using the ICP-MS method and by the FDA laboratory using its standard colorimetric method yi
236 nd data evaluated to support approval by the FDA of modifications of high-risk devices should be impr
239 HSV-1 (oHSV-1) was approved recently by the FDA to treat cancer, but further improvements in efficac
240 nd GECs, using drugs already approved by the FDA, can reduce both tumor size and invasiveness and cou
241 ere, we show how GSCs can be targeted by the FDA-approved drug mibefradil, which inhibits the T-type
247 trials based on the FDA classification, the FDA mild group may only need to be activated when the mo
248 ieties make specific recommendations for the FDA's consideration to reduce the burden of the proposed
250 confirmatory studies was extracted from the FDA's database of postmarketing requirements and commitm
251 ory process of US Federal agencies (e.g. the FDA's SNP pipeline for tracking foodborne pathogens).
255 -vapor additives that will better inform the FDA and other governmental bodies in discussions of the
256 ials from the National Cancer Institute, the FDA, members of the American Society of Image-Guided Sur
258 endo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the c
259 els during "off-label" administration of the FDA-approved iron chelator deferiprone evidenced signifi
260 cology renal dysfunction trials based on the FDA classification, the FDA mild group may only need to
265 pound resulted in being more active than the FDA-approved arsenic trioxide, with the most lipophilic
270 Our previous studies have shown that the FDA-approved BCL2 antagonist venetoclax has a beneficial
271 require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered.
274 n, a new dual-action compound related to the FDA-approved drug memantine, representing an uncompetiti
277 phthalmic devices initially approved via the FDA's PMA pathway between January 1, 1979 and December 3
278 Most ophthalmic devices approved via the FDA's PMA pathway have undergone extensive revisions, in
281 ncephalomyelitis virus were treated with the FDA-approved drug ritonavir using a dosing regimen that
283 um-containing anti-cancer nanodrug and three FDA approved nanodrugs, Abraxane, Marqibo, and Onivyde,
289 similarity clustering identified unexpected FDA-approved drugs that induced DNA damage, including cl
291 y the European Medicines Agency (EMA) and US FDA due to a lack of consensus and the different rates o
297 b and (90)yttrium-ibritumomab tiuxetan, were FDA-approved more than a decade ago but have been little
298 uses are important human pathogens for which FDA-approved vaccines do not exist and effective antivir
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