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Regulatory review of novel therapeutics--comparison of three regulatory agencies.

Regulatory review of novel therapeutics--comparison of three regulatory agencies.

http://www.wikidata.org/entity/Q36417844

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Fast-track drug approval in inflammatory bowel diseases Inconsistencies among European Union pharmaceutical regulator safety communications: a cross-country comparison Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries Regulatory approval time for hormonal contraception in Canada, the United States and the United Kingdom, 2000-2015: a retrospective data analysis.CETA and pharmaceuticals: impact of the trade agreement between Europe and Canada on the costs of prescription drugs.Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.Skin/nail infections with the addition of pertuzumab to trastuzumab-based chemotherapy.User fees and beyond--the FDA Safety and Innovation Act of 2012 How long does biomedical research take? Studying the time taken between biomedical and health research and its translation into products, policy, and practice.A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan FDA Policy and Cardiovascular Medicine.Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.Trends in clinical development timeframes for antiviral drugs launched in the UK, 1981-2014: a retrospective observational study.Protections for clinical trials in low and middle income countries need strengthening not weakening The potential exploitation of research participants in high income countries who lack access to health care Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study.Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999-2014 Developing standards for breakthrough therapy designation in oncology.A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.An appraisal of drug development timelines in the Era of precision oncology.Different contributions of internal reviewers and external experts to labelling decisions on therapeutic indications in new drug reviews in Japan.Successes and failures for drugs in late-stage development for Alzheimer's disease Clinical and regulatory features of drugs not initially approved by the FDA.FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.Clinical trial designs to obtain marketing authorization of drugs for haematological malignancy in Japan, the EU and the US.Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006-2015: a cohort study.Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study Cross-comparison of cancer drug approvals at three international regulatory agencies.Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.Evidence for Treatment-by-Biomarker interaction for FDA-approved Oncology Drugs with Required Pharmacogenomic Biomarker Testing.Use of the conditional marketing authorization pathway for oncology medicines in Europe.How do we avoid disaster when exiting the European Medicines Agency? Making the most of Brexit in pharmaceutical regulation.Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of 'deep' product reviews.Discrepancies in drug approvals: A global dilemma.Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov.A Model for Communication About Longshot Treatments in the Context of Early Access to Unapproved, Investigational Drugs.Evidence-based clinical management and utilization of new technology in European neurosurgery.The importance of greater speed in drug development for advanced malignancies.

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Regulatory review of novel therapeutics--comparison of three regulatory agencies.

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The New England Journal of Medicine

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Regulatory review of novel therapeutics--comparison of three regulatory agencies.

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Jenerius A Aminawung

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Joel B Braunstein

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Nicholas S Downing

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Nilay D Shah

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P2860

Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma.

Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996-1998.

Drug-review deadlines and safety problems.

Medical device innovation--is "better" good enough?

Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.

The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

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2284-2293

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scholarly article

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10.1056/NEJMSA1200223

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24

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366

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Harlan M. Krumholz

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2012-05-16T00:00:00Z

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224970616

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22591257

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3504361

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