Credibility And Crying Wolf: US FDA Petition Guidance Says Past Practices Can Count Against You
FDA is warning sponsors that a history of generic-delaying tactics may come back to haunt them when the agency considers whether a Citizen Petition is frivolous and potentially anti-competitive. But so will waiting too long to speak up.
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US FDA Amps Up "Name And Shame" Approach To Thwart Anti-Generic Tactics
New draft guidance says citizen petition abuses will be referred to FTC and publicly called out as attempts to delay ANDA approvals.
Moderna And The All-American Drug Pricing Hearing
Moderna’s time in the hot seat of the US drug pricing debate went about as well as it could for the company. The firm astutely set a tone of an All-American success story – but the hearing also showcased other ‘only in America’ themes.
Xtandi Still Faces Likely US Price Cut Even As It Avoids ‘March In’ Proceeding
The Biden administration decision not to pursue ‘march in’ proceedings for Pfizer/Astellas’ Xtandi sounds like good news. The reality is that the prostate cancer therapy is likely to face a more certain federal pricing intervention in the first year of the new Medicare ‘negotiation’ process.