Although officials say “breakthrough therapies” are “transformative” treatments that “hit you in the face” with their efficacy, the agency has yet to release clear guidelines to help industry determine when a product is worthy of the coveted designation.

Pharmaceutical manufacturers and FDA have enthusiastically embraced the “breakthrough therapy” program as a way to more quickly bring new drugs with substantial effects to patients in need. With two years of program experience now under their belts, agency and industry representatives talk about learnings and best practices that could be applied to the development and review of drugs outside the program.

Just five weeks before the US election, a Medtech Insight analysis shows medical device companies are spending more on Democrat Joe Biden’s campaign than on Republican Donald Trump’s.