Department of Health and Human Services January 10, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q8(R1) Pharmaceutical Development Revision 1.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance is an annex to the parent ICH guidance entitled ``Q8 Pharmaceutical Development'' (71 FR 29344, May 22, 2006) (ICH Q8). It provides further clarification of key concepts outlined in ICH Q8 and describes the principles of quality by design (QbD). The draft guidance is intended to show how concepts and tools (e.g., design space) outlined in ICH Q8 could be put into practice by the applicant for all dosage forms.