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Regulatory

A Guide to Using FDA’s eSTAR for Medical Device Submissions

Blogs, Medical Device, Regulatory /

The United States Food and Drug Administration (USFDA) introduced the electronic Submission Template and Resource (eSTAR) program as part of its efforts to modernize and streamline medical device submission. This initiative aims to streamline the 510(k)-submission pathway, which is essential for manufacturers seeking to bring new medical devices. As of Oct 1, 2023, the use […]

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ChatGPT Simplify Regulatory Affairs in Medical Devices

How LLMs like ChatGPT Can Simplify Regulatory Affairs for New Medical Devices

Blogs, Regulatory /

The European Union’s Medical Device Regulation (MDR) 2017/745 has significantly transformed the regulatory affairs landscape for medical device manufacturers by establishing strict requirements to ensure the safety and efficacy of devices before they reach the European market. These regulations demand detailed technical documentation, comprehensive clinical evaluations, and proactive post-market surveillance, creating substantial resource and time

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Barriers medical device adverse event reporting

Identifying Barriers in Reporting Medical Device Adverse Effects

Blogs, Pharmacovigilance, Regulatory /

Medical Devices are an important part of the healthcare delivery system used in the diagnosis, monitoring, and management of diseases. Recent scientific innovations and technological solutions have expanded the use of medical devices globally. Medical devices can include items such as apparatus, instruments, appliances, substances, in-vitro reagents, software, etc. and other related objects used for

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New Changes in EU Pharmaceutical Laws

Adapting to Changes in EU Pharmaceutical Laws

Blogs, Regulatory /

The European Union (EU) has long been recognized as a global leader in pharmaceutical legislation. In light of evolving healthcare needs, patient care, and technological advancements, the EU  amended 2 of their legislative frameworks on April 10th, 2024, named Directive on medicinal products for human use and the Regulation on authorisation and supervision of medicinal products for

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Role EMA Policy 0070 in Global Clinical Trials and Regulatory Practices

What EMA Policy 0070 Means for Global Clinical Trials and Regulatory Practices

Blogs, Clinical Regulatory, Regulatory /

In recent years, the pharmaceutical industry has been under increasing pressure to improve transparency, particularly when it comes to sharing clinical trial data. As the demand for open access to clinical research grows, regulatory bodies are stepping up to ensure that public health decisions are made based on comprehensive, accessible information. The European Medicines Agency

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Integrating Real-World Data into Regulatory Practices of Electronic Health Records and Medical Claims

Blogs, Pharmacovigilance, Regulatory /

As the healthcare and pharmaceutical industries increasingly turn to data-driven solutions, the integration of real-world data (RWD) into regulatory decision-making has emerged as a key focus for enhancing pharmaceutical practices. Utilizing data from Electronic Health Records (EHRs) and medical claims can provide valuable insights into patient care and treatment outcomes. This strategy has the potential

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EU Updated SOHO Regulations in 2024

The Future of ATMPs under EU’s Updated SoHO Regulations

Blogs, Clinical Regulatory, Regulatory /

The Advanced Therapy Medicinal Products (ATMPs) regulation was and covers gene therapy, somatic cell therapy, and tissue-engineered products. The ATMP’s requirements for the development, manufacturing, approval, and post-marketing surveillance for these products are regulated under regulation (EC) No. 1394/2007 and Directive 2001/83/EC in the European Union (EU). Stringent regulatory agencies, like the European Medicines Agency

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Navigating the New Requirements for Diversity in Clinical Trials

Blogs, Clinical Regulatory, Regulatory /

In recent years, the emphasis on diversity in clinical trials has become more prominent, reflecting the need for studies on more diverse populations to gather more accurate clinical findings. The lack of diversity in participants can create an obstacle to understanding the safety and efficacy of new medicines, making it more difficult to understand the

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Key updates in ICH Q2 and Q14 guidelines for biologics

What Biologics Developers Need to Know about ICH Q2 and Q14 Revisions

Blogs, Regulatory /

The rapid advancement of biologics and the complexity of their development requires a meticulous approach to analytical procedures. With the revisions to the ICH Q2(R2) (Validation of Analytical Procedures) and the introduction of ICH Q14 (Analytical Procedure Development), biologics developers now have updated guidelines designed to address the unique challenges presented by these complex therapeutic

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Two advice pilots to improve clinical trials in Europe

Accelerating Drug Development with Europe’s New Clinical Trial Pilots

Blogs, Clinical Regulatory, Regulatory /

The journey from discovering a promising compound to its approval as a safe, effective drug is challenging and costly, involving rigorous clinical trials to ensure public health and patient safety. The European Union responds to the need for speed and efficiency by transforming how clinical trials are conducted. The Accelerating Clinical Trials in the EU

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