Industry is eagerly awaiting guidance on combination products, and after seven years the adverse-event reporting regulation may be at top of the agency’s queue.
US FDA's proposed rule on post-market safety reporting for combination products appears to finally be making its way to the top of the queue, with the agency acknowledging that it is among the next steps in modernizing the combination products review program.
The rule – which was first proposed in 2009 – aims to clarify post-marketing safety reporting requirements for...
The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.
A recent CDRH Learn module urges medical device manufacturers to report potential shortages early, even outside emergencies, to help prevent disruptions. Recent natural disasters underscore the need for resilient supply chains, and reported shortages may be added to an FDA list.
Siemens Healthineers anticipates €400m-€500m tariff impact by 2026 but says it will mitigate losses through structural changes and pricing. Despite a revenue decline in diagnostics due to China’s VBP, diagnostics transformation activities, including cutting product, were “successful."
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.
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.
The US FDA has announced its user fees for fiscal 2026, which are based on a figure of $455,000 for a PMA.
A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.
