In the wake of the ever-evolving regulatory landscape, life science companies must be attentive to the various pathways that the FDA...

In today’s dynamic business landscape, uncertainty is a constant challenge. Every business, regardless of size or industry, faces a...

The Food and Drug Administration (FDA) has recently released a draft guidance document aimed at the healthcare and medical device...

The world of medical devices is rapidly evolving, bringing about remarkable advancements in how we diagnose, treat, and manage patient...

Post-market surveillance (PMS) is crucial for the ongoing safety and effectiveness of medical devices after they hit the market. As...

On June 4, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of Elsa , a new generative artificial intelligence (AI)...

In the wake of Brexit, the United Kingdom has created its own set of rules for different industries, including medical devices. The UK...

n the fast-paced world of medical device regulation, keeping up with changes is crucial. One of the most significant shifts is the FDA's introduction of the electronic Submission Template and Resource (eSTAR) for 510(k) submissions. This move aims to make the submission process smoother, increase clarity, and ultimately improve patient access to safe medical devices. For regulatory operations and quality leaders in medical device companies, understanding eSTAR's details i

The European Medical Device Regulation (EU MDR) continues to pose challenges for medical device manufacturers as they strive for compliance.

For medical device companies, compliance with international quality standards is essential to ensure product safety, regulatory approval, and market access.

Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing the medical device industry by enabling adaptive, data-driven...

Artificial Intelligence (AI) is rapidly transforming the pharmaceutical and biotechnology industries, offering powerful tools to accelerate drug discovery, enhance clinical trial efficiency, and optimize regulatory decision-making.

The pharmaceutical and biotech industries operate under intense regulatory scrutiny, with the U.S. Food and Drug Administration (FDA) ensuring compliance with Current Good Manufacturing Practices (cGMPs) and other regulatory requirements...

For medical device companies, compliance with FDA regulations is not just a legal obligation—it is critical to ensuring patient safety, product quality, and business success. FDA inspections play a key role in verifying that companies meet regulatory requirements, and failure to comply can lead to serious consequences, including warning letters, product recalls, import bans, and even legal action.

The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) by regulating donor eligibility and screening protocols.

Artificial Intelligence (AI) is revolutionizing healthcare, particularly in the medical device sector.

The FDA has released a draft guidance, Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics, outlining proposed updates to its policies and procedures for the accelerated approval pathway.

Informed consent is a cornerstone of ethical clinical research, but the FDA is now pushing for approaches that place patients at the heart of this process.

The Biosimilar User Fee Act (BsUFA) has been a key factor in expediting biosimilar approvals and enhancing regulatory efficiency in the U.S. Under the newly introduced BsUFA III, the FDA has launched the Regulatory Science Pilot Program, aimed at accelerating biosimilar development through cutting-edge research and regulatory practices.

The Global Unique Device Identification Database (GUDID) has become a cornerstone of regulatory compliance and supply chain transparency in the medical device industry.