U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

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Presentation transcript:

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

The Inspection is Over – What Happens Next? Possible FDA Compliance Actions Patricia Holobaugh FDA Center for Biologics Evaluation and Research Division of Inspections and Surveillance

The End of the Inspection Form FDA-483 is presented and discussed You may respond in a letter - send to address on the Form FDA-483. You may also ask the FDA investigator for the Headquarters Center address

The inspection report is written by the FDA investigator and sent to the Center. The Center evaluates the report and determines the corrective action, and classifies the inspection. NAI, VAI or OAI We write a letter following most inspections

Possible Actions for OAIs Actions for Inspected Party Actions on Applications

Actions for Inspected Party Warning Letter One or more activities is in violation of laws or regulations. Failure to take action may result in administrative or regulatory action without further notice 15 day response Posted on FDA web page

Actions for Inspected Party Initiate CI Disqualification Notice of Initiation of Disqualification Proceeding and Opportunity to Explain (NIDPOE) Posted on FDA web page Disqualified investigators may not receive investigational products No requirement to issue warning letter before NIDPOE

Actions for Inspected Party Refer to FDA Office of Criminal Investigations Injunction Seizure Prosecution Debarment if convicted of felony on FDA-related charges

Actions on Applications Clinical Hold The Center may impose a clinical hold of a drug/biologic study 21 CFR Or Disapprove a device study 21 CFR

Actions on Applications Reject the Data FDA may determine that the data are unreliable (inaccurate / incomplete) The remaining data would need to be reanalyzed. Might require an additional study Might delay approval of a BLA/NDA/PMA

Actions on Applications Terminate IND / Withdraw IDE Ends all studies Sponsor recalls all unused drugs/devices Unless immediate hazard, requires Part 16 hearing

Actions on Applications Withdraw Approval of NDA and PMA Revoke BLA

Actions on Applications Application Integrity Policy Agency will defer substantive review of applications Untrue statements of material facts; pattern or practice of wrongful acts; bribes Require corrective action plan

How to Find Investigator Inspection History CDER ormation/EnforcementActivitiesbyFDA/ ucm htm CBER nceRegulatoryInformation/ComplianceActivities/ ucm htm CDRH Submit request under Freedom of Information Act

FDA’s Electronic Freedom of Information Reading Room FOI/ElectronicReadingRoom/default.htm Warning letters Clinical Investigators NIDPOEs and NOOHs for disqualification proceedings Disqualified and restricted CIs Presiding officer decisions Firms under Application Integrity Policy

Compliance References Regulatory Procedures Manual warning letters, untitled letters, judicial actions Application Integrity Policy Debarment list Bioresearch Monitoring compliance programs RunningClinicalTrials/default.htm Good Clinical Practice references

CBER’s Bioresearch Monitoring Branch Main phone Branch Chief Pat Holobaugh FAX