Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during ...

Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to ...

The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

Understanding how packaging levels interact and support overall package integrity is critical for ensuring regulatory ...

Taking a proactive approach to compliance can help minimize regulatory risks, avoid submission delays, and ensure continued ...

Examine how medical device manufacturers can improve the economics and reliability of orthopedic implants by rethinking both material selection and processing strategies. Ultra-high-molecular-weight ...

Pharma organizations understand the regulatory stakes of GxP operations, but many still rely on paper-driven processes and disconnected systems that make compliance reactive rather than routine. Batch ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...