Have FDA’s generic approvals helped with competition? Researchers say too early to tell

RAPS

11 October 2019 - Amid increasing abbreviated new drug application approvals, efforts by the US FDA to promote generic drug development in areas where competition is lacking and for shortage-prone drugs have yet to make a noticeable impact, according a paper published in JAMA Network Open on Friday.

Since 2017, FDA has stepped up its efforts to promote generic drug competition by offering priority reviews for certain ANDAs, a new competitive generic therapy designation and by providing a list of drugs that lack generic competition.

The agency has also looked to increased generic competition as a means of preventing drug shortages and has taken steps to facilitate the development of complex generics, which have been a particularly challenging area of development for generic drug makers.

Read Regulatory Affairs Professional Society article

Michael Wonder

Posted by:

Michael Wonder

Posted in:

US , Regulation , Generic medicine