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Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products--a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products. [ABSTRACT FROM AUTHOR]

Dietary supplements, including those containing botanical ingredients and botanical-derived compounds, have been marketed to consumers globally for many decades. However, the legislative framework for such products remains inconsistent across jurisdictions internationally. This study aims to compare the regulatory framework of botanical food supplements in the EU, USA, Canada, Australia, New Zealand, India, Japan, and China. The study also aims to investigate and describe safety assessment criteria for botanical food supplements where they are present in the above said jurisdictions, and attempts to analyze whether these criteria are suitable for addressing the toxicological risks associated with the use of botanical food supplement products, based on the evaluation of reported adverse effects related to botanical food supplement use as examples. Finally, this study discusses some future issues that need further attention, such as the consideration of less than lifetime exposures, potential for misidentification, and adulteration of botanical supplements by pharmacologically active substances. It is concluded that the regulatory approaches towards botanical food supplements differ significantly across jurisdictions. In addition, national authorities are increasingly considering having more regulatory oversight for such products. Further consideration of the actual impact of adverse events arising from botanical food supplement usage will be helpful in guiding such decisions. [ABSTRACT FROM AUTHOR]

The global trend towards increased demand for organic food, greener environments, and the integration of biological control agents into pest management strategies has greatly enhanced the need for biopesticides. Biopesticides are made from micro-organisms or other natural substances and are, hence, generally environmentally friendly. However, despite their great potential—and in part due to regulatory challenges—relatively few biopesticides have been registered and commercialised in Nigeria compared to other African countries, such as South Africa and Kenya. Biological active agents are so diverse that applying the same safety standards to all of them is almost impossible. A comparative review of risk assessment processes of Nigeria's biopesticide regulations with other developing African countries (South Africa and Kenya) and developed regions (the European Union and the United States of America) was conducted. Prolonged field testing, lack of bridged risk assessments, and technical checklists were identified as key factors hampering the research and development of biopesticides in Nigeria. Suitable amendments to the existing regulations guiding biopesticide formulation and utilisation in Nigeria are recommended. Risk assessment matrices for microbial and biochemical pesticides and a scientific/technical checklist have also been developed. It is apparent that harmonisation and data exchange among countries in the region could enhance the advancement of scientific and technical knowledge for sustainable regulation of, and cross-border trade in, biopesticides. [ABSTRACT FROM AUTHOR]