Five of the six winners of the US FDA’s second batch of Commissioner’s National Priority Vouchers are for secondary indications. That is no accident, Commissioner Makary says.

US FDA’s new top drug regulator is promising to update regulatory standards for biosimilars to make the process look more like the generic drug pathway, where ‘we just characterize the molecule.’ Advancements in characterization are driving the ‘analytical revolution.’

US FDA’s new top drug regulator is promising to update regulatory standards for biosimilars to make the process look more like the generic drug pathway, where ‘we just characterize the molecule.’ Advancements in characterization are driving the ‘analytical revolution.’

The newly issued Make America Healthy Again strategy report suggests that FDA leaders are doing a good job of feeding ideas to the Trump Administration, rather than having the agency agenda dictated from above.

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

The US FDA has navigated one round of layoff notices, but more cuts could be coming. Here are three potential scenarios.