Firms Urge FDA to Develop Guidance on Combination Product Reviews
Manufacturers and industry groups urged the FDA to develop guidance on its processes for assigning a lead center for the review of a combination product.
In a comment to the agency on topics to be considered by the agency’s Combination Product Policy Council, Johnson & Johnson suggested focusing on aligning approval requirements among CDRH, CDER and CBER.
J&J also asked for further clarification of the data needed for combination product approval and on the types of products and manufacturing processes that may require changes in GMP and inspection requirements.
J&J and other industry commenters also urged the agency to outline methods for resolving scientific and regulatory disagreements among reviewing centers.