Tag: US Food and Drug Administration

Industry Focus Areas, Medical

The next technological frontier in pharmaceutical manufacturing

March 22, 2021

Via: Manufacturing Tomorrow

For pharmaceutical companies, every step of the production line and every aspect of their processes need to be approved by the regulator. Although this provides security, it also presents the challenge of how to incorporate changes into production. Flexibility is […]

Industry Focus Areas, Medical, Regulations

FDA takes cautious approach to new regulations for OEM and third-party device servicers

May 29, 2018

Via: Mass Device

The US Food and Drug Administration has cited insufficient evidence regarding public health concerns to warrant new regulatory requirements for original equipment manufacturers (OEM) and third-party servicers of medical devices, but will take less formal steps to ensure safety and […]