New MaPP (Manual of Policy and Procedures) 6004.3 (here) fully outlines the internal process that FDA will go through for reviewing and recommending safety label changes (SLCs) for NDAs, BLAs, and ANDAs.  It also discusses the process for FDA-mandated and -ordered label changes “when implementing section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which describes requirements for safety labeling changes (SLCs) for approved drugs under the Food and Drug Administration Amendments Act of 2007 (FDAAA).”

For the most part, this guidance applies when it comes to SLCs to NDAs and BLAs, but the impact on ANDAs (especially when an approved RLD is no longer a marketed) is included in the MaPP.  ANDAs must revise their labels to conform to the designated RLD upon which the ANDA is based and FDA will notify ANDA sponsors of any SLC.  But, for those where there is no RLD, FDA takes the lead on advising on an SLC that may be necessary.

The MaPP is very detailed and discusses the Agency’s internal requirements.  It also discusses the public posting of SLCs once the changes have been implemented.  Also of interest to ANDA sponsors- the MaPP reaffirms that SLC shall not hold up the approval of a pending ANDA when the SLC is made just prior to OGD taking an approval action.