A new guide from the U.S. Food and Drug Administration (FDA) provides recommendations and updated information to help sponsors comply with the expedited safety reporting requirements for human and biological products as part of a New Drug Application (IND) (21 CFR .) are examined 312.32 im Code of Federal Regulations) or as part of a bioavailability (BA) or bioequivalence (BE) study that is exempt from IND requirements (21 CFR 312.64 (b) and 320.31 (d) (3)).
The guide defines terms used for safety reporting, provides recommendations on when and how to submit a safety report, and provides information on other safety reporting issues raised by sponsors. The guidance also provides recommendations on the two IND safety reporting regulations (21 CFR 312.32 (c) (1) (i) (C) and 312.32 (c) (1) (iv)) that require an assessment of aggregated data.
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The new guide also brings together content from the Final Industry and Auditor Guide to Safety Reporting Requirements for INDs and BA / BE Studies (December 2012) and from the Draft Industry Guide to Safety Assessment for IND Safety Reporting (December 2015).
The new FDA guidelines also include revised recommendations originally described in the 2015 draft guidelines on: planned unblinding of safety data and effects on study integrity; increased flexibility in terms of the party reviewing aggregated safety information for IND safety reporting purposes; Clarification of the scope and methodology of aggregate analyzes; and clarification regarding the security surveillance plan, including what should be included in the plan.
Modifications made by Michael Causey