PDF/A distribution stalled: FDA does not (yet) accept PDF/A for submissions
We do not use PDF/A at all because it is not accepted by the FDA in the publication of regulatory submissions. It also does not work with our current version of our submission publishing software, CoreDossier (Documentum). In fact, we are constantly struggling to keep our documents in Acrobat 5, as opposed to version 6 & 7 because of publication problems, particularly with the tabular format use in many of our nonclinical and clinical reports.
Perhaps others in the pharmaceutical industry have a different situation?
Elaine R. Lowell
Regulatory Affairs Documentation Supervisor
Vertex Pharmaceuticals Incorporated
130 Waverly Street
Cambridge, MA 02139-4242
Perhaps others in the pharmaceutical industry have a different situation?
Elaine R. Lowell
Regulatory Affairs Documentation Supervisor
Vertex Pharmaceuticals Incorporated
130 Waverly Street
Cambridge, MA 02139-4242
jhagmann - 19. Jan, 20:23
