Regulatory Landscape Archives

Navigating Real-World Data Standards in
Drug and Biological Product Submissions: A Comprehensive Guide

In December 2023, the U.S. Department of Health and Human Services, in collaboration with the Food and Drug Administration (FDA), released a groundbreaking guidance document titled "Data Standards for Drug and Biological Product Submissions Containing Real-World Data." This guidance is a

2023:A Year of Regulatory Revolution in
Life Sciences

2023: A Year of Regulatory Revolution in Life Sciences 2023 was a whirlwind year for the life sciences industry, with regulatory changes and advancements coming at a breakneck pace. Here's a quick throwback on some of the key highlights: Regulatory Landscape:

Predetermined Change Control Plans (PCCPs)
for Machine Learning Medical Devices (MLMDs)
Guiding Principles

Predetermined Change Control Plans (PCCPs) for Machine Learning Medical Devices (MLMDs) Guiding Principles Artificial intelligence (AI) and machine learning (ML) are rapidly transforming healthcare. MLMDs are medical devices that use AI and ML to enhance their performance and capabilities. However, the

FDA’s Electronic Submission Template for
Medical Device 510(k) Submissions

FDA's Electronic Submission Template for Medical Device 510(k) Submissions The Food and Drug Administration (FDA) is taking a significant step forward in streamlining the process for submitting premarket notification (510(k)) submissions for medical devices. This guidance document is designed to introduce

Navigating Regulatory Change in the
Life Sciences Industry: Key Changes
and Your Roadmap to Readiness

Navigating Regulatory Change in the Life Sciences Industry: Key Changes and Your Roadmap to Readiness In the rapidly evolving life sciences landscape, organizations are finding resilience to be a cornerstone of success, especially in the face of challenges like economic pressures,

Ensuring Regulatory Compliance in Medicinal Product Manufacturing: The Importance of CMC Practices

The Chemistry, Manufacturing, and Controls (CMC) of a medicinal product encompass all the essential information related to the manufacturing process, quality control release testing, product specifications, stability, and the manufacturing facility with its support utilities. CMC regulatory affairs and compliance serve

Tag: Regulatory Landscape

Navigating Real-World Data Standards in
Drug and Biological Product Submissions: A Comprehensive Guide

2023:A Year of Regulatory Revolution in
Life Sciences

Predetermined Change Control Plans (PCCPs)
for Machine Learning Medical Devices (MLMDs)
Guiding Principles

FDA’s Electronic Submission Template for
Medical Device 510(k) Submissions

Navigating Regulatory Change in the
Life Sciences Industry: Key Changes
and Your Roadmap to Readiness

Ensuring Regulatory Compliance in Medicinal Product Manufacturing: The Importance of CMC Practices

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A Guide to Notifying Clinical Investigations for Medical Devices in the UK

FDA’s New Electronic Submission
Standards What Biopharma Companies
Need to Know

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