Prior Approval Supplement

Prior Approval (PA) "Prior Approval Supplements" supplement submission fora major change for which distribution of the product made using the change cannot occur prior to FDA approval as provided in 21 CFR 314.70 and 21 CFR 601.12. 

A supplement [Changes Being Expected (CBE), Changes Being Expected in 30 Days (CBE-30), or Prior Approval Supplement (PAS)] can be submitted to the agency prior to implementation, and, if necessary, an inspection can be performed by a PAT team or PAT certified investigator before implementation. 

Filing documentation—A prior approval supplement with all data including the accelerated stability data is required. This change should also be documented in the annual report along with the long-term stability data. 

Filing documentation—Prior approval supplement including accelerated stability data plus an annual report showing longterm stability data. 

Filing documentation—Prior approval supplement with justification for change long-term stability data must be reported in the annual report. 

Filing documentation—A prior approval supplement must be filed with justification for the change. Long-term stability data should be submitted in the annual report. 

Prior Approval Supplement For a major change (substantial potential to have effect on quality and performance), a supplement has to be submitted to the FDA for approval before a product made with the change is distributed. There is also a provision for Prior Approval Supplement Expedite Review Requested for public health reasons and if the delay in approval may cause any substantial concerns for the applicant. 

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

Processing changes affecting the Change in the type of process used Updated batch record Stability Updated batch record—stability Prior approval supplement... 

Prior approval supplement (all infonnation including accelerated stability data) annual report (long-term stability data). 

Stabihty One batch with three months accelerated stability data reported in prior approval supplement and long-term stability data of first production batch reported in annual report. 

An f2 value less than 50 does not necessarily indicate lack of similarity. If the sponsor is of the opinion that the differences observed related to this calculation of f2 are typical for the drug product involved in this SUP AC situation, an appropriate j ustification can be submitted, but only as part of a prior approval supplement. This justification should include additional data to support the claim of similarity, as well as supporting statistical analysis (e.g. 90% confidence interval analysis). If this justification is not found acceptable, the potential effect of the proposed change on the differences in dissolution on bioavailability should be determined. 

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