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Regulatory safety evaluation of nanomedical products: key issues to refine
Nanotechnologies enable great opportunities for the development and use of innovative (nano)medicine s . As is common for scientific and technical...
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The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities
This brief paper aims to describe the Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard launched by the US Food and Drug Administration...
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Evaluation of the Suppressive Capacity of Regulatory T Cells in Food Allergy Research
Regulatory T cells (Treg) exert a crucial role in the suppression of exacerbated T helper (Th) cell responses, including those of type 2 Th (Th2)...
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Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities
BackgroundDespite the worldwide need for increased access to safe and effective medicines, there is a lack of innovative medicines in many low- to...
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Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience
The World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products (SBPs; also called biosimilars) were adopted by the...
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Biosimilars: Principles, Regulatory Framework, and Societal Aspects
A “generic” version of a biopharmaceutical may be introduced after patents and other exclusivity rights expire. However, the generic paradigm as it...
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A systematic quality evaluation and review of nanomaterial genotoxicity studies: a regulatory perspective
The number of publications in the field of nanogenotoxicology and the amount of genotoxicity data on nanomaterials (NMs) in several databases...
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Pharmacogenomic biomarker information on drug labels of the Spanish Agency of Medicines and Sanitary products: evaluation and comparison with other regulatory agencies
This work aimed to analyse the pharmacogenetic information in the Spanish Drug Regulatory Agency (AEMPS) Summary of Products Characteristics (SmPC),...
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Regulatory Requirements and Applications of Physiologically Based Pharmacokinetic Models
Physiologically based pharmacokinetic (PBPK) models have become a key tool to reduce the uncertainty and assure the best benefit-risk decisions in a...
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Patenting Nanomaterials: Regulatory Aspects
Promising nanotechnologies can open a new avenue for research and development in multiple disciplines and influence a wide range of commercially...
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Regulatory Aspects and Bottlenecks for Nutraceuticals
Nutraceuticals help in the prevention and therapy of many illnesses. The market of nutraceutical is expanding and there is an increase in the demand...
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Regulatory Considerations of Biosimilars in Cancer
In the fast-evolving field of cancer treatment, the introduction of biosimilars has brought about significant changes in the available therapeutic...
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Nanosimilars: A Scientific or A Regulatory Debate?
The paper highlights the necessity for a robust regulatory framework for assessing nanomedicines and their off-patent counterparts, termed as...
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Regulatory Aspects of Synbiotics-Based Delivery System
The daily demand for functional foods offering nutrition and health benefits is increasing exponentially. On human health, the combination of...
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Evaluation of Circ_0000977-Mediated Regulatory Network in Breast Cancer: A Potential Discriminative Biomarker for Triple-Negative Tumors
Previous investigations have revealed that circular RNAs (circRNAs) play pivotal roles in cancer development and progression by participating in...
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Regulatory Aspects for Clinical Applications of Nanophytomedicines
This chapter discusses the various regulatory guidelines of Food and Drug Administration (FDA) and International Cooperation on Cosmetic Regulation...
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Evaluation of the Performance of the Gulf Cooperation Council Centralised Regulatory Review Process: Strategies to Improve Product Authorisation Efficiency and Quality
BackgroundThe Gulf Centralised Committee for Drug Registration (GCC-DR), as part of the Gulf Health Council (GHC), enables the consolidated...
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Regulatory Considerations for Translational Forensic Science
To be effectively deployed in operational forensic science, innovative methods must meet the regulatory standards for their jurisdiction. This...
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Regulatory Aspects for Polymeric Micelles
In recent decades, nanoformulations have been at the forefront of pharmaceutical research, posing new problems for the scientific community,...
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A Dynamic Model for GMP Compliance and Regulatory Science
PurposeTo propose a dynamic model designed to investigate the underlying principles of regulatory science and assess the effectiveness of...
