Wouldn’t you like to stop routine FDA inspections and forego pre-approval inspections?
Manufacturers finally have some clarity on which CGMP requirements apply when producing a combination product.
Fewer resources and more requirements are hindering the process.
The final guidance is part of the agency’s effort to provide better patient access to new devices via stronger and streamlined clinical trials.
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.