FDA Guidance for Indutry M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
Title:
FDA Guidance for Indutry M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073257.pdf
Content:
This guidance primarily addresses the organization of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived and biological products).