Drug Approval
Concept
Vocabulary Service
Overview
subject area of
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A review of the two major regulatory pathways for non-proprietary low-molecular-weight heparins Academic Article
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Alternatives to Placebo-Controlled Trials Academic Article
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Biosimilars for psoriasis: clinical studies to determine similarity Academic Article
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Biosimilars for psoriasis: preclinical analytical assessment to determine similarity Academic Article
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Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice Academic Article
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Canada’s laws on pharmaceutical intellectual property: the case for fundamental reform: Figure 1: Academic Article
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Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016 Academic Article
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Clinical and Technical Considerations for Brain PET Imaging for Dementia Academic Article
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Combination pharmacotherapy to prevent cardiovascular disease: present status and challenges Academic Article
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Determining optimal sample sizes for multistage adaptive randomized clinical trials from an industry perspective using value of information methods Academic Article
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Do we need a new approach to making vaccine recommendations? Academic Article
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Does GLP enhance the quality of toxicological evidence for regulatory decisions?: TABLE 1. Academic Article
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Ebola Virus in West Africa: Waiting for the Owl of Minerva Academic Article
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Emergency use authorisation for COVID-19 vaccines: lessons from Ebola Academic Article
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Establishing Therapeutic Equivalence of Complex Pharmaceuticals: The Case of Dabigatran Academic Article
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Expert consensus recommendations on the use of randomized clinical trials for drug approval in psychiatry- comparing trial designs Academic Article
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Genetic and Chemical Screening in Human Blood Serum Reveals Unique Antibacterial Targets and Compounds against Klebsiella pneumoniae Academic Article
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Global Myeloma Trial Participation and Drug Access in the Era of Novel Therapies Conference Paper
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Harmonization of HTA--based reimbursement and regulatory approval activities: a qualitative study. Academic Article
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Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences Academic Article
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INDs for PET Molecular Imaging Probes—Approach by an Academic Institution Academic Article
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In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches Academic Article
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Is the GAIN Act a turning point in new antibiotic discovery? Academic Article
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Model‐Informed Drug Development for Anti‐Infectives: State of the Art and Future Academic Article
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New Antithrombotic Drugs Academic Article
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New approaches to rewarding pharmaceutical innovation Academic Article
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New treatments for dementia. Myth, magic, and science. Academic Article
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Objective Responses in Patients with Malignant Melanoma or Renal Cell Cancer in Early Clinical Studies Do Not Predict Regulatory Approval Academic Article
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Optimal sample size determinations from an industry perspective based on the expected value of information Academic Article
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Oral anticoagulant use in addition to antiplatelet therapy for secondary prevention in acute coronary syndrome: current perspectives Academic Article
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Pediatric drug data in Canadian drug monographs: a descriptive analysis Academic Article
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Phase 4 research: what happens when the rubber meets the road? Academic Article
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Preclinical pharmacokinetics, biodistribution, radiation dosimetry and acute toxicity studies required for regulatory approval of a Clinical Trial Application for a Phase I/II clinical trial of 111In-BzDTPA-pertuzumab Academic Article
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Real-world studies no substitute for RCTs in establishing efficacy Academic Article
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Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes? Academic Article
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Regulatory decisions pertaining to aprotinin may be putting patients at risk Academic Article
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Rimonabant for prevention of cardiovascular events (CRESCENDO): a randomised, multicentre, placebo-controlled trial Academic Article
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Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology Academic Article
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Sensible guidelines for the conduct of large randomized trials Academic Article
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Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies Academic Article
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Surrogate Markers in Clinical Studies: Problems Solved or Created? Academic Article
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Switching to extended half-life products in Canada - preliminary data Academic Article
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The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020 Academic Article
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The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12–15 Years — United States, May 2021 Academic Article
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The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5–11 Years — United States, November 2021 Academic Article
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The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020 Academic Article
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The Advisory Committee on Immunization Practices’ Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines — United States, 2021 Academic Article
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The Data and Safety Monitoring Committee: Some final thoughts Academic Article
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The Guideline-Policy Gap in Direct-Acting Oral Anticoagulants Usage in Atrial Fibrillation: Evidence, Practice, and Public Policy Considerations Academic Article
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The Opportunity Cost of Capital Academic Article
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The Price We Pay for Progress: A Meta-Analysis of Harms of Newly Approved Anticancer Drugs Academic Article
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The United States Food and Drugs Administration Approves a Generic Enoxaparin Academic Article
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The Vioxx® legacy: Enduring lessons from the not so distant past Academic Article
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The cost of drug development: A systematic review Academic Article
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The granting of emergency use designation to COVID-19 candidate vaccines: implications for COVID-19 vaccine trials Academic Article
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Time for a regulatory framework for pediatric medications in Canada Academic Article
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Transforming an Academic Radiochemistry Facility for Positron Emission Tomography Drug cGMP Compliance Academic Article
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Trends in paediatric clinical pharmacology data in US pharmaceutical labelling Academic Article
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Trends in pregnancy labeling and data quality for US-approved pharmaceuticals Academic Article
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Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately? Academic Article
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Use of Pfizer-BioNTech COVID-19 Vaccine in Persons Aged ≥16 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, September 2021 Academic Article