Drug Approval Concept

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