Almost all changes to approved marketing applications, either New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and Premarket Application (PMA) are required to be reported to the FDA under the FD&C Act.
Procedures for submitting supplements for an NDA or ANDA are covered under 21 CFR 314.71.
There are three categories of postapproval changes; major, moderate and minor.
These changes are categorized based on their potential to affect the quality, identity, strength, purity or potency.
The timing of supplemental reports is affected by the three categories.
FDA reviews each supplement and Annual Report to determine if the sponsor can distribute drug product.
Premarket Approval Supplement (PMA) is required when a significant change affects the device’s safety and effectiveness.
Examples of required PMA supplements include: new indication for use, labeling changes, use of a different facility or establishment, changes in manufacturing methods or quality control procedures, etc.
There are several types of PMA supplements that are based on the how significant the changes affect the devices safety and effectiveness.