FDA Guides On Pathway For Competitive Generic Therapies

19 Feb 2019

• By Grace Montgomery

Draft guidance on the approval pathway for competitive generic therapies (CGTs) has been published by the FDA in the agency’s latest move to advance generic drug competition.

RoadClouds — The FDA has created a new pathway for CGTs • Source: Shutterstock

The US Food and Drug Administration (FDA) has released a draft guidance on competitive generic therapies (CGTs) in the agency’s latest move to increase generic competition.

FDA Commissioner Scott Gottlieb stated that the agency was “taking another step to encourage generic entry for drugs that face...