Drug Approval Concept

subject area of

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