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 ...

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a ...

Ultrasonic spray coating parameters such as drug-to-polymer ratio and carrier gas flow impact coating thickness/profile and ...

(Reuters) - U.S. drug regulators in September found quality control lapses at Moderna’s main factory including with equipment used to manufacture drug substance for its COVID-19 vaccine, according to ...

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 ...