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Streamlining Clinical Investigations for Medical Devices

Blogs, Clinical Regulatory, Medical Device, Regulatory /

Clinical investigations for medicinal devices are critical in order to advance healthcare and patient safety. Streamlining clinical investigations help accelerate the delivery of innovative solutions to patients, which ensures timely access to devices that would help diagnose and treat diseases. Simplifying regulatory processes, enhancing stakeholder engagement, and aligning with global practices fosters more rapid approvals. […]

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Third Party Review Program for Medical Devices

Blogs, Medical Device, Regulatory /

The onset of the pandemic highlighted many obstacles pertaining to medical devices used to detect and diagnose the virus, SARS-CoV-2. Many device manufacturers emerged with their concerns and requested for “Emergency-Use Authorization” (EUA) for their in vitro diagnostic medical devices used to help detect the virus. In response to this request, the US FDA provided

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SwissMedic: Strengthening Safety Signal Reporting for Veterinary Products

Blogs, Pharmacovigilance /

Efficiently detecting safety signals for veterinary products is crucial for safeguarding animal health and ensuring the well-being of both animals and humans. Rapid identification of potential risks allows for timely intervention, preventing widespread harm. Recognizing the significance of this, global authorities are actively working to fortify safety signal reporting. Establishing regulatory guidelines ensures a standardized

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Effective Communication for the Safe Use of Biosimilars

Blogs, Labeling /

Biosimilars and interchangeability with biologics has been a topic of discussion for regulatory authorities worldwide, including their definitions and varying requirements per regions. However, a key requirement or standard for interchangeability requires applicants to provide sufficient information to demonstrate bio similarity. This reflects in the biosimilars labelling requirements where prescription drug and biological product labels

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Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid

Blogs, Pharmacovigilance /

Pharmacovigilance in India has come a long way over the last few years especially for proactively detecting safety signals for pharmaceutical products. It is an indispensable component of the pharmaceutical industry in India, ensuring the safety and efficacy of drugs in the market. This comprehensive field includes various sub-categories, each contributing to the overall goal

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The Use of Item Response Theory in Clinical Outcome Assessments

Blogs, Clinical Regulatory, Regulatory /

Clinical outcome assessments (COAs) are a critical component of clinical trials and regulatory submissions for regulatory agencies like the US FDA. The US FDA defines a COA as a “measure that describes or reflects how a patient feels, functions, or survives”; COAs provide important information to the US FDA on the effectiveness of therapies so

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Enhancing Medical Device Cybersecurity

Blogs, Medical Device /

The integration of wireless, Internet, and network-connected capabilities in medical devices, coupled with the frequent exchange of health information, necessitates robust cybersecurity controls. A cybersecurity threat can compromise the safety and/or effectiveness of a device by compromising the functionality of any asset in the system if there is an absence of adequate cybersecurity control. Regulatory

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Development of Pharmacovigilance Training Modules for US-based Educational Institute

Case Studies, Pharmacovigilance /

Customer Requirement: A USA-based educational institute specializing in providing training courses to its subscribers was looking to develop a course on pharmacovigilance. This course would be the first of its kind for the educational institute and would aim to provide a robust foundational knowledge base of pharmacovigilance, including key activities, processes, and the regulations surrounding

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Utilizing Real-World Evidence for Medical Devices

Blogs, Medical Device, Regulatory /

Recent years have witnessed a surge in clinical practice data generation outside of trials, driven by advanced signal detection technologies and expanded database capabilities. The integration of real-world data (RWD) with artificial intelligence (AI) tools is reshaping regulatory and medical decision-making. Various user-generated practice data types are stored in centralized databases, offering valuable longitudinal observations

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