On 13 April 2022, the FDA's Office of Generic Drugs (OGD) published a draft manual of policies and procedures, (MAPP 5240.10) outlining how new drugs and drug-device combination products will be classified as complex products for purposes of generic drug development.
This Manual of Policies and Procedures (MAPP) details how the Office of Generic Drugs (OGD) will classify which approved new drug products and drug-device combination products are assigned to the Center for Drug Evaluation and Research (CDER) are complex products for generic drug development purposes.
A complex product generally includes one or more of the following five features:
1. A complex active ingredient
2. A complex route of delivery
3. A complex dosage form or formulation
4. A complex drug-device combination product
5. “[C]omplexity or uncertainty concerning the approval pathway or [a] possible alternative approach [that] would benefit from early scientific engagement”
If a drug product does not have any of the five features mentioned above, OGD will classify that product as a non-complex drug product for generic drug development purposes.
An enhanced pathway for FDA discussions may be available to developers who plan to submit an abbreviated new drug application (ANDA) that references a complex product.