ARTICLE | Politics & Policy

FDA smoothing path for generic combo, complex drugs

November 28, 2017 6:26 PM UTC

FDA Commissioner Scott Gottlieb Tuesday announced new policies intended to increase generic competition, especially for drug-device combination products and for drugs that have been difficult for FDA to approve as generics such as those that are applied topically or inhaled.

To work around patents on delivery devices such as auto-injectors or inhalers, generic manufacturers must create slightly different products and change the instructions for how their product is used. In the past, FDA has declined to approve a generic product if the instructions for use differ from the branded product. ...