'Combination Product Agreement Meetings' Coming Soon From US FDA

The meetings are tied to requirements from the 2016 21st Century Cures legislation. They could offer more development certainty for sponsors by allowing informal agreements with the agency on pre- and post-market issues.

businessman and businesswoman are shaking hands and exchanging folder after agreement was reached

The US FDA is finishing guidance explaining a new meeting type for combination product sponsors that will allow pre-submission development agreements – another attempt to smooth the approval process for a sector where historically hurdles often arise.

Agreements are not expected to be binding under the new combination product agreement meeting (CPAM), but could cover a wide variety of issues. John Barlow Weiner, associate director for policy...

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