How the FDA is Helping the Generic Drug Industry

To help facilitate efficient and successful generic drug application and approval processes, the FDA has published, a Manual of Policies and Procedures (MAPP).  This 11-page guideline outlines abbreviated new drug application (ANDA) assessment practices for the Office of Generic Drugs (OGD).  The main goal is for the OGD is to better help companies in the generics business understand the processes and procedures for their drug approval in an effort to reduce the unnecessary back and forth in review cycles.  

 

The background

In recent years, the amount of “paperwork” associated with ANDA’s have increased substantially. With the addition of the MAPP, the FDA is hoping it will ultimately reduce duplicative and unnecessary work, and increase FDA’s efficiency and effectiveness. This enables applicants to develop high-quality re-submissions and reduces the number of subsequent cycles to approval. Traditionally, the review process consisted of a three-tiered approach using time and resources throughout the department.   The new guideline hopes to cut down on these processes and only involve primary and secondary assessors.

  

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Here is what the MAPP entails

  • Emphasizes the use of templates and assessment tools provided by the sub-disciplines that focus the primary assessment of quality, bioequivalence, labeling data, or information on the critical attributes of the application. 

  • Clarifies the roles and responsibilities of assessors and helps them determine whether their application meets requirements for approval.

  • Presents a guideline to clearly communicate to applicants what deficiencies must be corrected for their ANDAs to be approved.

The FDA hopes that this guideline will help get generic drugs to market faster and expand medication options for the population as a whole.  Importantly, the organization believes this, in turn, will allow for FDA experts to focus more attention on the development of novel therapeutics and biologics or challenging policies and procedures.

 

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