Health Affairs

Complex Clinical Laboratory Tests Can Benefit From Design Controls

Diagnostic test developers, including clinical laboratories, responded to the COVID-19 pandemic with inspiring creativity to meet patient testing needs. These developers found unique ways to enable ...
MD&M East

Design Controls: Are They Worth the Effort?

In January 1990, FDA published Device Recalls: A Study of Quality Problems (55 FR 21108, May 22, 1990). The study reported that 44% of quality problems were attributed to errors or deficiencies that ...

2 Day Efficient Batch Record Design and Review in Compliance with FDA, EMA, and EU GMP Requirements Course (ONLINE EVENT: Apr 9th - Apr 10th, 2026)

The "Efficient Batch Record Design and Review (Apr 9th - Apr 10th, 2026)" training has been added to ResearchAndMarkets.com's offering. This online training course provides a comprehensive and ...
JD Supra

FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug

The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...
MD&M East

A Complete Guide to Medical Device Design and Development

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...