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FDA Releases New Draft Guidance Regarding Clinical Trial Data Monitoring Committees | Burr & Forman

FDA Releases New Draft Guidance Regarding Clinical Trial Data Monitoring Committees | Burr & Forman
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Burr formanUs food drug administrationNational institutes of healthDrug administrationClinical trial sponsorsClinical trial data monitoringNational institutesInstitutional review boardsTrial steering

Metacognitive therapy home-based self-help for anxiety and depression in cardiovascular disease patients in the UK: A single-blind randomised controlled trial

In a randomized controlled trial, Adrian Wells and colleagues test the effectiveness of adding self-help metacognitive therapy to cardiac rehabilitation in reducing anxiety and depression.

United kingdomSouth africaGreater manchesterUnited kingdom generalWestern capeZara husainRebecca mcphillipsRebecca andersonMark tomlinsonCintia faijaAvi atwalWendy clarkeBeth cooperNational audit of cardiac rehabilitationAintree university hospitalsManchester university

Libtayo® (cemiplimab) Approved by the European Commission as the First Immunotherapy in Second Line Recurrent or Metastatic Cervical Cancer Irrespective of PD-L1 Expression Level or Tumor Histology

/PRNewswire/ Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) approved Libtayo® (cemiplimab) as monotherapy.

United kingdomRegion flamandeSouth koreaGeorged yancopoulosRegeneron velocimmuneTaylor ramseyPrnewswire regeneron pharmaceuticals incTrial steering committeeRegeneron velocimmune technologyEuropean network for gynaecological oncological trialUniversity hospitals leuvenEuropean unionRegeneron pharmaceuticalsRegeneron pharmaceuticals incRegeneron genetics centerDrug administration

SCCT2022 Presents Distinguished Awards

During the Society of Cardiovascular Computed Tomography 17th Annual Scientific Meeting (SCCT2022), three awards were presented to cardiovascular imaging leaders. Here is summary background on the worthy recipients and each award presented July 15, 2022, in Las Vegas, Nev.

United statesUnited kingdomFlorida international universityCity ofMichelle williamsStephan achenbachEdwin van beekArthurs agatstonMarc dweckLas vegasEric williamsonDavid newbyMichael blahaSociety of cardiovascularDuring the society of cardiovascular computed tomographyTrial steering committee

Evaluation of the Growth Assessment Protocol (GAP) for antenatal detection of small for gestational age: The DESiGN cluster randomised trial

Matias C Vieira and colleagues evaluate the Growth Assessment Protocol (GAP) for antenatal detection of small for gestational age in the DESiGN cluster randomised trial.

New zealandUnited statesCity ofUnited kingdomUnited kingdom generalUniversity collegeNew south walesSandra essienMarcelo candaEmma waymanMuna nooriFrancesca hanksJanet cresswellAnna davidLaura camarasaFiona ghalustians