FDA Merges Guidances on Safety Reporting Requirements
The FDA has published a new draft guidance aimed at helping sponsors comply with expedited safety reporting requirements for drugs and biologics.
FDA officials have said loud and clear recently that they want sites and sponsors to stop overreporting suspected adverse events because the noise created by so many unnecessary reports means important safety signals sometimes get lost (CenterWatch Weekly, June 14).
The new draft guidance merges the agency’s 2012 final guidance on safety reporting requirements for investigational new drug (IND) and bioavailability/bioequivalence studies with its 2015 draft guidance on safety assessments for IND safety reporting.
The new guidance does not feature the investigator provisions originally included in the 2012 guidance. The FDA said it will issue a new guidance for investigators.
Comments on the new draft guidance are due by Sept. 26.
Read the guidance at https://bit.ly/3xLg3pM.