ARTICLE | Politics & Policy
EMA selects adaptive licensing pilot products
June 7, 2014 12:27 AM UTC
EMA selected the first two products to be included in a pilot project of an adaptive licensing program through which the agency will evaluate granting early approval in a restricted patient population. The selected compounds are undisclosed. The agency launched the pilot project in March and said it has received 20 applications to date. According to EMA, qualifying products should address an unmet need and should be in the early stages of development. ...