metaMe Health CEO and ex-Takeda executive Tim Rudolphi and partner firm Indegene’s senior vice president Marut Setia explained their plans for the FDA-authorized, gut-directed hypnotherapy Regulora, including an openness to outcomes-based pricing and the wider go-to-market strategy.

metaMe Health CEO and ex-Takeda executive Tim Rudolphi and partner firm Indegene’s senior vice president Marut Setia discuss with Scrip plans for the FDA-authorized, gut-directed hypnotherapy Regulora, including an openness to outcomes-based pricing and the wider go-to-market strategy.

A landmark legal case over 3D-printed guns doesn’t involve FDA – but it is worth considering how the issues are likely to apply to the drug approval process in years to come. The right to bear arms may rely on the Second Amendment, but the key for FDA is how courts look at the First Amendment in the context of new technology.

A year and a half after FDA issued a draft guidance to help makers of devices that rely on additive manufacturing, the agency has finalized the document in its bid to get ahead of the technology. The final guidance makes minor clarifications, but for the most is identical to the draft.