Overcoming Barriers to Entry for Complex Generic Oral Inhalation Drug Products

On-Demand Webinar Recording

In this webinar...

Generic orally inhaled drug products are considered complex products under the Generic Drug User Fee Amendments reauthorization in 2017 (GDUFA II), due to their complex route of delivery, and because many are also complex drug-device combination products.  Development of generic orally inhaled products has been challenging, especially compared to non-complex products. Kimberly Witzmann, MD, Team lead in the Division of Therapeutic Performance, Office of Generic Drugs at FDA, will present some of the challenges for orally inhaled drug products, and how research performed under OGD’s Regulatory Science Research program can help to overcome these barriers to entry for these complex products, which will ultimately lead to the approval of safe, effective, and affordable orally inhaled generic products made available to the American public.

Presenters

  • Kim Witzmann, MD, Medical Officer, Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, FDA