Guidance: Drug Safety Information

To fulfill this commitment, FDA issued for comment a draft guidance titled FDA s Drug Watch for Emerging Drug Safety Information in May... 

FDA has carefully reviewed the comments it received on the draft guidance (30 comments were submitted to the public docket)6 and during the public hearing. This final version of the guidance reflects our consideration of these comments, as well as our experience with posting emerging drug safety information. 

Anon (2001) ICH S7A Safety pharmacology studies for human pharmaceuticals Fed Reg 66 36791 — 36792. http //www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/ucm074959.pdf... 

Information on existing or new excipients can be described and provided to the FDA in an NDA directly. Alternatively, the manufacturers of excipients may prepare and submit type IV Drug Master Files (DMF) to support the use of an excipient in one or more NDAs. The DMFs are discussed in FDA s regulations under 21 CFR Section 314.420 and the FDA-issued Guidance for Drug Master Files (8). When authorized by the DMF submitter (i.e., the excipient manufacturer) and cross-referenced by an NDA submitter, the FDA reviews the DMF to make determinations on the safety, manufacture, and quality of the excipient use in the new drug that is the subject of the then pending NDA. The DMF becomes active when reviewed in conjunction with the review and approval of an NDA. 

Food and Drug Administration . Contains information on food additives and premarket approval, including guidance in designing and interpreting studies to assess safety ( FDA Redbook ). 

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