Several provisions are aimed at accelerating device innovation and access to medical products.
FDA releases achievements of its Combination Product Review Program, along with next steps for the near term.
The search for better ways to stop bleeding may benefit from international partnerships.
The finger-prick alternative may help diabetic patients more effectively monitor their condition.
An adequate structure must be in place to support a QMS.
Severity of harm is what ultimately matters most in terms of protecting patients from the consequences of use errors.
Some key factors that companies should not overlook when developing drug-device products.
The agreement will create a pure-play infusion therapy company.
Some insights on integrating stability testing requirements into a device organization’s plan to make combination products.
Highlights include leveraging big data, streamlining clinical trial design, reducing healthcare-associated infections and toughening up on cybersecurity.