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.
They also requested that the agency focus on aligning approval requirements among CDER, CBER and CDRH, as well as on international pharmacopeia standards — and to outline methods for resolving scientific and regulatory disagreements among reviewing centers.
Johnson & Johnson, Pfizer and Allergan — as well as BIO and the International Pharmaceutical Aerosol Consortium on Regulation and Science, which represents companies including AstraZeneca, GlaxoSmithKline, Mylan and Boehringer Ingelheim — suggested major topics for discussion by the FDA’s Combination Product Policy Council, made up of representatives from the agency’s three reviewing centers and the Offices of Combination Products and Special Medical Programs.
Both J&J and Pfizer 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. In addition, Allergan asked for more specific guidance on where to include information covering the device portions of their products in electronic application files.