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UNDERSTANDING THE DIFFERENCES

Understanding the nuances between different FDA reporting categories, our team of dedicated, passionate leaders ensures the appropriate pathway is identified to maximize the efficiency of approval compliance while minimizing costs and time towards a desired outcome.

PRIOR APPROVAL SUPPLEMENT (PAS)

Used for significant changes to an ANDA that require prior FDA approval before implementation. As these changes can often impact the safety and efficacy of the drug product, PAS submissions involve more comprehensive data and documentation and are often subject to increased scrutiny due to the nature of the requested changes. These can include:

 

  • Major changes to the manufacturing process, location, or technical manufacturing expertise and equipment. 

  • Major changes to the formulation or dosage form. 

  • Major changes to labelling or artwork. 

CHANGES BEING EFFECTED (CBE-0/CBE-30)

Typically used for moderate to an active ANDA. These types of changes are often determined to pose moderate to little risks to the safety and efficacy of the drug product but need to be verified with supporting data. These can include:

  • Certain changes to the container closure system. 

  • Certain labelling or artwork changes. 

  • Certain changes to manufacturing process or equipment. 

 
Changes Being Effected have two sub-categories:

  1. Changes Being Effected in 30 Days (CBE-30): Changes that fall into this category require the submission of a supplement that must be made to the FDA at least 30 days before the changed drug product is distributed

  2. Changes Being Effected (CBE-0): Changes subject to this type of supplement contain changes for which distribution can occur when FDA receives the supplement.

MINOR CHANGES

Used for minor changes that have minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product.  Notification of such changes is submitted to the FDA as part of the Annual Report.

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