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“If we can’t work everything out, that’s fine. Let’s just put pen to paper on what we have worked out and maybe enter part of the puzzle,” said Shuren. Read More
The firm’s CAPA procedure failed to ensure that the information gathered about nonconforming products and quality issues reached the person responsible for dealing with them. Read More
The FDA’s regulatory process for manufacturers of new moderate-risk devices has “remained largely unchanged since it was first implemented 40 years ago,” Commissioner Scott Gottlieb said. Read More
The association pointed to the upwards 200,000 computers across more than 150 countries that were victims of the WannaCry ransomware attack earlier this year. Read More
The shift to increased patient input for device development and clinical trials in recent years has been more challenging than expected, according to participants at the FDA/CMS Summit. Read More