Former deputy commissioner will also likely push increased use of biomarkers and more flexibility in off-label communication, among other reforms.
President Donald Trump's choice of Scott Gottlieb to head the US FDA could signal efforts to bring reforms among a variety of fronts, perhaps none more notable than how the agency approves generic drugs.
Gottlieb, returning for what would be his third stint at the agency, has been a staunch proponent for flexible approval...
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.
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.
The FDA said new molecular entity application reviews increased and cost less in fiscal year 2024, a potentially encouraging sign for industry.
