Changes Being Effected Supplement

CBE "Supplement-Changes Being Effected" supplement submission for certain moderate changes for which distribution can occur when FDA receives the supplement as provided in 21 CFR 314.70 and 21 CFR 601.12. 

Changes being effected supplement (accelerated stability data for MR and no stability data for IR) Annual report (longterm stability data for MR and IR)... 

Prior approval supplement (accelerated stability data) for MR and changes being effected supplement forIR... 

Changes being effected supplement annual report (long-term stability test data). 

Stability One batch with three months accelerated stability data reported in Changes Being Effected supplement and long-term stability data of first production batch reported in annual report. 

Changes Being Effected supplement (all infonnation including accelerated stabil-... 

I. Chemistry Documentation. Application/compendial product release requirements. Notification of change and submission of updated executed batch records. Significant body of information available One batch with three months accelerated stability data reported in changes being effected supplement and long-term stability data of first production batch reported in annual report. 

Labeling changes, normally classified as major changes, that FDA specifically requests be implemented using a changes being effected supplement. 

Changes being effected supplement (CBE) with new data submitted in annual report... 

Post approval commitments for NDAwere not met in a timely manner. For example One of the post approval commitments was to modernize and optimize the analytical method for the detection of degradants. An FDA letter reminded your firm that the firm had not yet fulfilled this commitment. Validation studies were conducted by the firm and the validation report was approved. Yet, it was not until a Change Being Effective Supplement was submitted by the firm to the FDA and the improved method implemented. 

The methods for shortening an expiration date is through a Changes-Being Effected supplement (21 CFR 314.70 or 21 CFR 601.12). 

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