Kate Rawson
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Generic Drug Sponsors May Discuss Alternative BE Approaches During Pre-ANDA Meetings
Teva requested the change to the draft guidance, arguing that otherwise the meetings would be “completely one-sided conversations.”
Generic Drug Sponsors May Discuss Alternative BE Approaches During Pre-ANDA Meetings
Teva requested the change to the draft guidance, arguing that otherwise the meetings would be “completely one-sided conversations.”
US FDA Oncology Managers Extol Assessment Aid’s Virtues
The Oncology Center of Excellence’s shared review document program is very popular with US FDA oncology staff, review managers said during an OCE anniversary event, along with the Project Facilitate expanded access support program.
AI In Drug Development: Avoid The ‘Flashiness,’ And Simply Ask ‘Does It Fit?’ – US FDA’s ElZarrad
The Center for Drug Evaluation and Research’s medical policy chief says artificial intelligence can aid patient recruitment and increase trial diversity, but warned of “unique” potential pitfalls for sponsors.
Three Gene Therapies, Moderna Metabolic Drug In Inaugural START Class; CBER Oversubscribes
Seven rare disease programs make up the first round of participants in the US FDA’s ‘Operation Warp Speed’-style program. Sponsors will benefit from ‘rapid, ad hoc’ communication with the agency.
Beyond CAR-Ts: Cell-Based Gene Therapy Sponsors Are ‘Branching Out,’ CBER’s Marks Says
As sponsors explore development in autoimmune and infectious diseases, plus a range of hematologic and solid tumors, manufacturing processes can be centralized or decentralized, but Marks says the FDA is ‘neutral’ on that decision.