Office of Generic Drugs Explains Research Conducted in First Year of GDUFA II

Regulatory NewsRegulatory News
| 18 July 2019 | By Zachary Brennan 

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Thursday released a report on the two dozen research grants awarded related to complex generics in 2018, as well as the research done in seven other areas, including data analytics and combination products. 

Thanks to the second iteration of the Generic Drug User Fee Amendment (GDUFA II), OGD was able to turn its research and scientific activities into 136 new product-specific guidances (PSGs) to aid generic drug development in FY 2018. In addition, OGD oversaw 83 pre-abbreviated new drug application (ANDA) meeting requests in FY 2018 for complex products that do not have PSGs.

“Data analytics research supports the implementation of the commitments through the creation of a knowledge base regarding complexity of approved drug products that integrates knowledge from three categories: (1) drug product information (including complexity classification); (2) regulatory information (e.g., new drug application) approval date and PSG publishing date); and (3) pharmacoeconomic information (e.g., drug sales). This knowledge base helps identify future science and research needs and plan the development of PSGs,” OGD explains.

On the research topic of generic drug-device combination products, OGD’s Office of Research and Standards awarded a contract to a research group in the Imperial College London to develop a systematic way to evaluate patient perception of dry powder inhaler airflow resistance, evaluate patient preferences for a particular airflow resistance range and determine if the patient preference for this range varies with disease/severity or class of drug product.

OGD’s research also touched looked further into long-acting injectables and implants, with 15 active research products exploring biorelevant in vitro-in vivo correlations (IVIVCs) for biodegradable injectable poly lactide-co-glycolide (PLGA) microspheres and to investigate potential peptide PLGA interactions during product manufacturing and use, among other topics.

Several research grants were also awarded during FY2018 for advances in predictive dissolution and physiological models of oral drug absorption. In addition, several external and internal projects were active to model orally inhaled and nasal drug products.

OGD also has developed modeling and simulation toolsets to direct the design and evaluation of pharmacokinetics (PK) or comparative clinical endpoint bioequivalence (BE) studies, enabling the assessment of alternative BE approaches for complex products. “Our approaches have been applied in various regulatory activities, including consultation responses, citizen petition responses, development of product-specific guidances (PSGs), pre-abbreviated new drug application (ANDA) meetings and ANDA reviews related to complex products,” FDA said.

Office of Generic Drugs FY 2018 GDUFA Science and Research Report


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