FDA is getting tougher on cancer drug approvals. But stakeholders on all sides-industry, regulators, and patient groups-say that's probably a good thing. Under the leadership of Richard Pazdur, MD, the controversial director of FDA's newly formed Office of Oncology Drug Products, the agency is raising the bar for getting cancer drugs on the market.
Ramsey Baghdadi
"Good drug, bad development." That is how Food & Drug Administration director of the Office of Oncology Drug Products Richard...
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The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
The US FDA may ask sponsors for permission to train AI models using data from new drug applications. Alternatives to animal testing could be a test case.
The bolus of untitled letters signals the FDA's approach to enforcement of the final rule on the presentation of the major statement in direct-to-consumer TV ads in a clear, conspicuous and neutral matter.
The CDC and its Advisory Committee on Immunization Practices reportedly are planning to make unsubstantiated claims about COVID-19 vaccine adverse events with little recourse for manufacturers and other stakeholders.
Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.
Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!
The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.
