Robert Califf marked his one-year anniversary as the commissioner of the US Food and Drug Administration by discussing the first year of his second term as the agency’s chief executive and his vision for the future.
Running the US Food and Drug Administration is nothing new for Robert Califf, who took the reins of the agency in February 2022. A cardiologist by trade, Califf also ran the agency in the final year of the Obama administration. But, he noted during a recent fireside chat hosted by the Alliance for a Stronger FDA, that was a more “genteel” time.
In reprising his role as commissioner, not only has Califf had to grapple with a global pandemic, but a more...
J&J’s global head of MedTech Digital envisions AI-powered connected operating suites within a decade. In an interview with Medtech Insight, Shan Jegatheeswaran discusses how J&J, together with partners like NVIDIA and AWS, is laying the foundation for open platforms for standardized surgeries.
Healthtechs are reflecting on the resignation of Sam Roberts as chief executive of NICE and how medtech assessment program changes underway at the England and Wales HTA body might be impacted.
A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.
NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.
The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.
Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.
Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.
