Nielsen has been covering pharma most of his life, reporting on everything from ANDAs to Zika vaccines. He believes that the user fee system needs to stop using Roman numerals and enjoys discussing R2-D2 almost as much as talking about 351(k).
US FDA says it is offering firms formatting and structure advice on how best to respond to a Form 483 to speed the clearance process. Industry worries the agency is in fact creating new GMP obligations.
US FDA has resumed posting its complete response letters, but the CRL for AbbVie’s Botox follow-on, the last one issued before the agency’s pause, is still worth lingering over because of what it says about drug development and government reimbursement.
Health Canada is offering sponsors a no-fault inspection before the new ICH GCP guideline goes into effect, and the bid reveals how regulatory oversight is becoming something of a recruiting tool.
The FTC has told a federal appeals court that what J&J did to competition matters more than what it meant to do. That, along with a big recent Takeda verdict, should change how you think about every defensive patent move.
The EU’s debut Joint Clinical Assessment was run on a drug that exposes every trap waiting for orphan developers in 2028.
The UK's new "notifiable trial" route can shave weeks off your timeline, but only if you sequence your jurisdictions like a chess player rather than a tourist.
The AI trial pilot survived its own architects' departure. For one more month, the docket is where it gets decided.
The EU pharma reform package has a 2028 implementation date. That is not a reason to wait.
Meetings often get a bad rap around the office water cooler or in popular media, be it through Jack Donaghy’s “Four Chairs. Four!” line in 30 Rock or the
