An Overview of Challenges and Opportunities in the Development of Complex Generic Drug Products

On-Demand Webinar Recording

In this webinar...

"Complex generic drugs" are a large and diverse group made up of drug products with complex active ingredients or sites of action and complex drug-device combination products. Examples include some long-acting injectable drugs, ophthalmic drugs, topical medicines, and orally inhaled products. While critical to patients, these therapies have historically been difficult to develop as generics compared to non-complex generic drugs.

Dr. Xiaohui "Jeff" Jiang, Deputy Director, Division of Therapeutic Performance in the Office of Generic Drugs at FDA, will share specific examples of regulatory science research at FDA that demonstrate progress in facilitating timely development of complex generic drug products.

Presenters

  • Dr. Xiaohui "Jeff" Jiang, Deputy Director, Division of Therapeutic Performance in the Office of Generic Drugs, FDA