As the agency's Office of Pharmaceutical Quality releases its annual report highlighting last year's efforts to advance distributed and point-of-care manufacturing, OPQ director Kopcha tells the Pink Sheet of plans to focus on activities advancing the use of artificial intelligence in manufacturing process control this year.

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.