Therapeutic Innovation & Regulatory Science

Incorporating Innovative Techniques Toward Extrapolation and Efficient Pediatric Drug Development

Pediatric Antibiotic Pack Size Compliance With the Dosage Regimen: A Descriptive Study.

A Pilot Experiment in Responding to Individual Patient Requests for Compassionate Use of an Unapproved Drug: The Compassionate Use Advisory Committee (CompAC)

Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development

Adaptive Design: A Review of the Technical, Statistical, and Regulatory Aspects of Implementation in a Clinical Trial.

Youth Experience With Community Pharmacy Services and Their Perceptions Toward Implementation of Medication Therapy Management Services by Community Pharmacists in the Western Region of Saudi Arabia

Improving Clinical Trial Participant Prescreening With Artificial Intelligence (AI): A Comparison of the Results of AI-Assisted vs Standard Methods in 3 Oncology Trials.

Open Payments and the US Clinical Landscape.

Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials:: Results of a Preliminary Study

How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient Organizations.

Pharma Collaboration for Transparent Medical Information (phactMI) Benchmark Study: Trends, Drivers, Success Factors, and Value of Globalization in Medical Information

Biomaterials Evaluation: Conceptual Refinements and Practical Reforms

Awareness and Collaboration Across Stakeholder Groups Important for eConsent Achieving Value-Driven Adoption

Exact Unconditional Tests for Dichotomous Data When Comparing Multiple Treatments With a Single Control.

Barriers for Pharmaceutical Innovation With Focus in Cancer Drugs, the Case of Mexico.

Pulmonary Arterial Hypertension: A Case Study in FDA Expedited Program Designations

Comparison of Sample Size by Bootstrap and by Formulas Based on Normal Distribution Assumption

Assessing Outsourcing Oversight Practices and Performance.

Influence of Expedited Programs in the United States on Oncology Drug Development in Japan

Use of Proxy Variables to Determine the Impact of Protocol Complexity on Clinical Research Site Productivity

Risk of Cleft Lip and/or Palate Associated With Antiepileptic Drugs: Postmarketing Safety Signal Detection and Evaluation of Information Presented to Prescribers and Patients

Unique Burdens of Pediatric Clinical Trials in Duchenne Muscular Dystrophy, April 20-21, 2017, Bethesda, Maryland, USA

In Vitro Skin Permeation Methodology for Over-The-Counter Topical Dermatologic Products.

Influence of Drug Lag on New Drug Label Revisions

How Do Drug Regulatory Bodies Deal With Potential Innovative Therapies?

Interdisciplinary Safety Evaluation and Quantitative Safety Monitoring: Introduction to a Series of Papers.

Breakthrough Therapy, PRIME and Sakigake: A Comparison Between Neuroscience and Oncology in Obtaining Preferred Regulatory Status.

A Novel Collaborative Approach to Building Better Clinical Trials: New Insights From a Patient Engagement Workshop to Propel Patient-Centricity Forward.

Incorporating Patient Advocates in Oncology Clinical Development: Lessons Learned From a Novel Pilot Program

Postmarketing Safety of Biosimilars: Current Status, Challenges, and Opportunities in the Spontaneous Reporting System.

Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework

Analyzing Upward Deviation of Actual vs Predicted Drug Sales in Japan for a Reasonable Drug-Pricing Policy.

Developing, Planning and Conducting an Interim Analysis: Lessons From the DEVOTE Cardiovascular Outcomes Trial (Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events)

Benefits and Risks of Nonsteroidal Anti-inflammatory Drugs: Methodologic Limitations Lead to Clinical Uncertainties

Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA

An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements

Special Considerations for Proprietary Name Review: Focus on Products That May Be Prescribed “As Directed”

Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies.

Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study.

An Overview of the Drug Registration Requirements for Export to Tanzania, Nepal, and Cambodia.

Comparison of Brief Summary Formats Through a Health Literacy Lens

Single-Study Approvals: Quantum of Evidence Required.

Sentiment of Media Coverage and Reputation of the Pharmaceutical Industry.

Improving the Standards of Reporting of Clinical Trial Data.

Updating the Clinical Picture of Facioscapulohumeral Muscular Dystrophy: Ramifications for Drug Development With Potential Solutions.

Combined-Indications Significance Level of Multiple Related Indications Developed Simultaneously.

Patient Feedback on a Warfarin Action Plan Used in a Local Australian Physician Practice Setting.