FDA Guidance for Industry: Format and Content for the CMC Section of an Annual Report, 1994
Title:
FDA Guidance for Industry: Format and Content for the CMC Section of an Annual Report, 1994
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/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070565.pdf
Document Type:
FDA guidance for industry
Content:
These FDA guidelines described what information CDER expects in the Annual Report for NDA´s, ANDA´s and AADA´s. This also includes the information on ongoing stability tests.