That statutory regulatory language never quite keeps up with change in science is an ‘existential crisis,’ former FDA official says. California district court ruling preventing FDA enforcement action against stem cell clinics was ‘a little bit disrespectful to the agency.’
A district court judge’s ruling that the US Food and Drug Administration could not prevent two stem cell clinics from administering unapproved stromal vascular stem cell treatments shows how difficult it is for the agency to regulate novel products.
Eva Temkin, a partner at King & Spalding, noted that one of the problems for the FDA is that it...
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
