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Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation
This article examines the development of MAPPs, from inception of the concept, to the establishment of this trans-Atlantic initiative, and examines challenges for the future. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Schulthess, D., Baird, L. G., Trusheim, M., Unger, T. F., Lumpkin, M., Hoos, A., Garner, S., Gavin, P., Goldman, M., Seigneuret, N., Chlebus, M., Van Baelen, K., Bergstrom, R., Hirsch, G. Tags: Global Perspectives Source Type: research

Implementing Benefit-Risk Assessment for the Periodic Benefit-Risk Evaluation Report
Conclusions: A structured, systematic approach to defining a medicine’s B-R profile will help ensure compliance with this ICH objective for the PBRER. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Warner, M. R., Wolka, A. M., Noel, R. A. Tags: Product Safety Source Type: research

Challenges in the Ethical Review of Research Involving Complementary and Integrative Medicine
In this report, we describe these issues that were the focus of a workshop that was part of an international conference held in Seoul, Korea, on April 4, 2015. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Cooper, J. A., Borasky, D., Rosenfeld, S., Sugarman, J. Tags: Product Safety Source Type: research

Improving Regulatory Education: Can We Reconcile Employers Expectations With Academic Offerings?
Conclusions: The challenges in implementing such a model, as described by survey participants, are significant but can be addressed. The barriers to implementation of regulatory curricula based on a competency-based education model should be better understood so that academic programs can educate highly skilled regulatory professionals. Such a workforce could best contribute to the delivery of high-quality, safe, and effective medical products. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Drago, D., Shire, S., Ekmekci, O. Tags: Regulatory Science Source Type: research

Regulatory Informatics Reveals Minimal Residual Disease Trends in Hematologic Malignancies
Conclusion: The application of informatics tools to regulatory science can evaluate the role and context of MRD as it evolves in the changing pharmaceutical landscape. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Rach, E. A., Kalra, S., Williams, T., Hung, H.-L. Tags: Regulatory Science Source Type: research

Trend Analysis of FDA Warning Letters Issued to Medical Products About Violations to Current Good Manufacturing Practices (CGMP) Between 2007 and 2014
Conclusions: The issuance number of warning letters increased during 2009-2011. Medical device manufacturers received the largest numbers of letters. The issuance number and type of warning letters were greatly influenced by changes in FDA’s internal enforcement procedures, drug policies and regulations, as well as other departments’ regulations. Manufacturers should comply with regulations voluntarily and respond promptly to policy changes. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Wang, L., Zheng, H., Ren, X., Sun, H. Tags: Regulatory Science Source Type: research

A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary
The Copenhagen Centre for Regulatory Science (CORS) and Biopeople at the University of Copenhagen held a workshop in May 2015 titled "Patient Involvement in Medicines Development and Approvals: A Paradigm Shift Towards True Patient Impact in Medicines Development and Regulatory Science" that acknowledged the importance of having patients more involved in the entire process of medicines research and development (R&D) and life cycle management. Four key stakeholders, representing patients, academia, industry, and regulatory authorities, each gave their view and perspective on the status and challenges of current patient ...
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Borup, G., Bach, K. F., Schmiegelow, M., Wallach-Kildemoes, H., Bjerrum, O. J., Westergaard, N. Tags: Regulatory Science Source Type: research

Sterile Compounding Pharmacies: States That Do and Do Not Require Compliance With USP Versus FDA 483s
Traditional pharmacy compounding involves the modification of a dosage form to fit the needs of a patient, as prescribed by the patient’s physician, and serves a vital need within the health community. Unites States Pharmacopeia–National Formulary (USP-NF) General Chapter <797>, titled "Pharmaceutical Compounding—Sterile Preparations," is the gold standard to which modern-day pharmacists compounding sterile products are held. In this article, the FDA 483 inspection reports received by sterile compounding pharmacies were divided into 2 categories: facilities in the United States that require complian...
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Wilson, M. Tags: Special Section on Pharmaceutical Compounding Source Type: research

Navigating Through a Complex and Inconsistent Regulatory Framework: Section 503B of the Federal Food Drug and Cosmetic Act Outsourcing Facilities Engaged in Clinical Investigation
The integrity of unbiased clinical data is essential to the future of the health care system by facilitating the discovery of lifesaving medicines and ensuring investigational drugs are safe and effective. Since 2002, the US pharmaceutical industry has invested over $500 billion, which is the largest research and development investment of any sector of the US economy. As a consequence of this significant investment, pharmacy compounders and other stakeholders must be acutely aware of the consequences of noncompliance. Pharmacy compounders are required to navigate through a complex and ever-changing regulatory landscape gov...
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Palumbo, F. B., Rosebush, L. H., Zeta, L. M. Tags: Special Section on Pharmaceutical Compounding Source Type: research

Improving the Quality of Compounded Sterile Drug Products: A Historical Perspective
This article describes the history of the practice and regulation of pharmacy compounding, culminating in the passage by Congress of the Compounding Quality Act of 2014. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Cantrell, S. A. Tags: Special Section on Pharmaceutical Compounding Source Type: research

Pharmaceutical Compounding: Our First Foray Into Common Ground and Controversies
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Authors: Jenkins, L. Tags: Editorial Source Type: research

Global Innovators and Thought Leaders Across the Drug Information Industry to Gather in Philadelphia for DIA 2016
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 20, 2016 Category: Drugs & Pharmacology Tags: Announcement Source Type: research

Validation of Prognostic Marker Tests: Statistical Lessons Learned From Regulatory Experience
Despite concerted efforts to discover and validate prognostic biomarkers or signatures, few medical tests indicated for prognostic uses have been widely accepted by the clinical community. Even fewer, perhaps, are covered by public or private health plans. We were able to identify 6 prognostic marker tests that have been approved or cleared by the US Food and Drug Administration. The pivotal clinical studies for these prognostic marker tests exhibited a wide variety of designs and statistical analyses. From these experiences, we develop statistical points to consider for design, conduct, and analysis of successful clinical...
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Tang, R., Pennello, G. Tags: Statistics Source Type: research

Pharmaceutical Pricing Policies and Procedures in Saudi Arabia: A Narrative Review
This article discusses the pharmaceutical pricing policies and the impact of health drug prices on the public in the Kingdom of Saudi Arabia. A review of government and Saudi Food and Drug Authority (SFDA) policy documents, guidelines, and articles published in PubMed and other indexed journals (N = 10) was performed to identify the relevant literature. Results showed that the government appears poised and focused on the availability of better health care facilities to the Saudi population. The pharmaceutical market in Saudi Arabia commands a large portion of the pharmaceuticals market share in the entire Middle East regio...
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Khan, T. M., Emeka, P., Suleiman, A. K., Alnutafy, F. S., Aljadhey, H. Tags: Global Perspectives Source Type: research

Evaluation of Safety Profiles of Blood Cancer Drugs Approved in Japan
Conclusions: In cases where the SI is <1.0, no drug safety margin can be assured based on animal data. When extrapolating data from animal studies to safety assessment in clinical studies, safety profile would be one of aspects to be carefully considered in drug development, including postmarketing surveillance. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Kubota, S., Saito, K., Ono, S., Kodama, Y. Tags: Global Perspectives Source Type: research