(redirected from Complete Response Letter)
CRLCertificate Revocation List
CRLCenter for Responsible Lending
CRLCommunity Reference Laboratory (Dorset, UK)
CRLCenter for Research Libraries
CRLCentre Régional du Livre (French: Regional Book Center)
CRLClinical Reference Laboratory (Lenexa, KS)
CRLClinical Research Laboratories (various locations)
CRLComplete Response Letter (US FDA)
CRLCommunications Research Laboratory (Japan)
CRLCentre de Ressources en Langues (French: Language Resource Center)
CRLCentre Régional des Lettres (French: Regional Art Center)
CRLConsulting Radiologists, Ltd. (Minneapolis, MN)
CRLCommon Representation Language
CRLCore Reporting Level
CRLCommunications Research Laboratory
CRLCycle-Init Reverb Lockout
CRLCrown Rump Length (ultrasound fetal measurement)
CRLCenter for Research on Learning (University of Kansas)
CRLChina Resources Land (China Resources Group)
CRLChalk River Laboratories
CRLCertified Registered Locksmith
CRLCambridge Research Laboratory (Compaq)
CRLCancer Risk Level
CRLCustody Receipt Listing (US Air Force)
CRLContract Research Laboratory (various locations)
CRLCentre de Ressources Linguistiques (French: Center for Language Resources)
CRLCredit Risk Loan (finance)
CRLCurrent Rate of Load (shipping)
CRLChicago Rail Link
CRLContribution sur les Revenus de Locations (French: Rental Income Contribution; taxes)
CRLCoalition for Responsible Lending
CRLCeramics Research Laboratory (Nagoya Institute of Technology; Japan)
CRLCareer Resource Library
CRLCalifornia Redevelopment Law
CRLChemistry Research Laboratory
CRLCommon Runtime Library (computing)
CRLConsciousness Research Laboratory
CRLChalet Résidence Loisirs (French: Leisure Residence Chalet)
CRLCenter for Responsible Leadership (various locations)
CRLComputer Research Lab
CRLCentre de Réadaptation des Laryngectomisés (French rehabilitation center)
CRLCentro Retail Limited (Australia)
CRLCentral Regional Laboratory (EPA)
CRLCommon Runtime Language
CRLCanada Robotics Ltd. (British Columbia, Canada)
CRLCellule de Recherche en Linguistique (French)
CRLCountermeasure Readiness Levels
CRLCertified Reporting Limit
CRLCanons Regular of the Lateran (religious order)
CRLCountry Request Live
CRLCriminal Reference Letter (IRS)
CRLClinical Reference Library (database)
CRLComplete Reference Library (Mindscape)
CRLConventional Rotary Launcher
CRLCODA Readout Language
CRLConstruction Reference Line (engineering drawings)
CRLCOMSEC Requirements List
CRLCommercialization Readiness Level (NASA)
CRLCooperative Research Laboratory
CRLCoherent Reverse Link
CRLCricklewood Redevelopment Limited (UK)
CRLCable Running List (telecommunications)
CRLCommon Record Log
CRLChurngold Remediation Ltd
CRLCost Readiness Level (project cost estimation; US NASA)
References in periodicals archive ?
Lastly, the company has finished the outstanding drug product validation reports identified in the complete response letter, or CRL, which will be included in the NDA resubmission package.
Sarepta announced Monday after the market close the FDA issued a complete response letter for its NDA seeking accelerated approval for golodirsen injection for treating Duchenne muscular dystrophy, or DMD, in patients with confirmed mutation amenable to exon 53 skipping.
M2 PHARMA-August 12, 2019-Kala Pharmaceuticals Receives FDA Complete Response Letter for KPI-121 0.25% NDA and Plans to Respond with Data From STRIDE 3 Trial
M2 EQUITYBITES-August 12, 2019-Kala Pharmaceuticals receives complete response letter from the US FDA for KPI-121 0.25 percent new drug application
Biopharmaceutical company DURECT Corporation (Nasdaq:DRRX) on Monday reported a Complete Response Letter from the US Food and Drug Administration (FDA) for REMOXY ER (oxycodone) extended-release capsules CII.
The Company had previously attended the in-person Type A meeting with the FDA to discuss the Complete Response Letter (CRL) received in connection with the XYOSTED New Drug Application (NDA).
AstraZeneca said it had received a so-called complete response letter from the FDA stating that more clinical data were required before it could approve the combination of saxagliptin and dapagliflozin.
The authorityA alsoA issued a Complete Response Letter relating to the supplemental Biologics Licence Application (sBLA) of CimziaA to treat adult patients with active axial spondyloarthritis (axSpA).
11, the manufacturer, Novo Nordisk, said that in a complete response letter, the FDA has requested "additional cardiovascular data from a dedicated cardiovascular outcomes trial" before the review can be completed.
The FDA issued a complete response letter to the company, saying that the oral drug cannot be approved with the application in its current form, although the agency said that cladribine's effectiveness in treating relapsing remitting MS had been proved in its phase III trial, CLARITY (Cladribine Tablets Treating MS Orally).
Afterwards, in a so-called complete response letter (CRL) for the new drug application (NDA) of Brilinta (ticagrelor), the FDA asked for additional analysis of a study dubbed Plato without requiring further clinical studies.
The statement issued by Jazz Pharmaceuticals noted that the FDA's "complete response letter" said the new drug application for sodium oxybate cannot be approved "in its present form" and cited the need for more clinical studies.
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