Nagalakshmi S*, Sangeetha Priya S and Aravind R
DOI: 10.37421/2167-7689.2023.12.358
Software is revolutionizing how doctors practice medicine, customers control their health, and patients and providers interact. Software that can perform advanced medical functions software as a medical device is a game-changing innovation in digital health technology (SaMD). SaMD may diagnose ailments, prescribe medications and offer clinical treatment recommendations. The US FDA, EU and Australia TGA also specified general platforms. To overcome the challenges while interpreting software product fits into the medical device framework, IMDRF has developed different guidance including risk based categorization to determine possible levels of premarket reviews and Real-World Evidence (RWE).) IMDRF plays a similar function in enabling the regulators to risk-stratify submissions and focus resources on products that pose the greatest risk to patient safety. While SaMD products are not new, there are many new players in the SaMD space to better regulate iterative devices. One of the key goals is to identify the excellence of the SaMD Regulatory paradigm regulation of these products will need to radically change to accommodate new SaMD manufacturers and the technology’s rapid evolution and to harness SaMD’s ability to capture RWD to create a collaborative, innovative SaMD community. This review aimed to describe the regulatory and technical aspects of the software as a medical device and regulatory transformation of digital health rapidly expanding regulations by different health authorities.
Patel Hetvi*, Shah Krutarth and Joshi Yash
DOI: 10.37421/2167-7689.2023.12.359
Generic drug products played an important role in the health care system in global aspects especially in the middle income country and fully developed country. They play important role in the lowering the cost of medicine and provide the low cost treatment in targeted countries. Generic drugs have the same therapeutic value same as the innovator product. This study aims to achieve the comparison of the regulation of generic drug product regulation in Zimbabwe, USA, Canada and Europe. All of the targeted countries follows the common technical document format and also focuses on safety quality and efficacy of the drug product. Regulation of generic drug in Zimbabwe is easy compared to rest of the countries.
Randy Anderson* and Christabel Tan
DOI: 10.37421/2167-7689.2023.12.397
The United States Food & Drug Administration requires under Title 21 of the Code of Federal Regulations (21 CFR) Part 820.100, that medical device manufacturers must establish a system to address Corrective And Preventive Actions (CAPAs) to meet regulatory standards. This article provides insight into medical device quality issues relating to CAPA through the evaluation of warning letters issued by the US Food and Drug Administration (FDA) between 2013 and 2022. The results of this study indicate that despite the medical device regulations being in place since 1976 violations of 21 CFR 820.100 (CAPA related violations) continues to be a significant issue for medical device companies.
Pharmacy, as a crucial discipline within the healthcare system, has experienced significant evolution and development over the years. This comprehensive field encompasses various domains, including the discovery, production, and distribution of medications, patient care, and medication management. In this article, we will explore the dynamic nature of pharmacy, its vital role in modern healthcare, and the evolving responsibilities of pharmacists in providing optimal patient outcomes. The origins of pharmacy can be traced back to ancient civilizations, where medicine and pharmaceutical practices were intertwined.
DOI: 10.37421/2167-7689.2023.12.368
DOI: 10.37421/2167-7689.2023.12.369
Pharmaceutical compounds are a class of chemical substances that are specifically designed to treat; activated sludge is a popular wastewater treatment process that has been used for decades to remove a variety of pollutants from municipal and industrial wastewaters. This process involves the use of a mixture of microorganisms to break down organic matter in the wastewater, converting it into carbon dioxide, water, and other substances that are less harmful to the environment.
Pharmaceuticals are a class of emerging contaminants that have been increasingly detected in wastewater treatment plants around the world. These compounds, which include antibiotics, analgesics, hormones, and other drugs, are not completely removed by conventional wastewater treatment processes, including activated sludge. Several studies have investigated the removal of pharmaceuticals in activated sludge, and while the results are promising, the process is complex and depends on several factors. In this article, we will discuss the various factors that affect the removal of pharmaceuticals in activated sludge and the mechanisms involved in the process.
Several factors can affect the removal of pharmaceuticals in activated sludge, including the type of pharmaceutical, the concentration of the pharmaceutical, the Hydraulic Retention Time (HRT), the temperature, and the presence of other organic matter in the wastewater.
Different pharmaceuticals have different chemical structures, and this can affect their removal in activated sludge. For example, compounds with high hydrophobicity, such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and some antibiotics, are often poorly removed by activated sludge due to their low solubility in water.
DOI: 10.37421/2167-7689.2023.12.370
DOI: 10.37421/2167-7689.2023.12.371
Pharmaceutical Regulatory Affairs: Open Access received 499 citations as per Google Scholar report
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