FDA has set a panel meeting date in December that will include discussion of trial designs and potential indications for devices being developed to treat hypertension. Also, the advisory panel will look at an implantable device seeking approval for use in heart-failure patients.
Despite some significant clinical-trial challenges, focus remains high in industry on developing devices to treat hypertension. US FDA is looking to stay ahead of the progress with a newly scheduled Dec. 5 meeting of its Circulatory System Devices Panel.
"Clinical studies to evaluate the safety and effectiveness of these devices are progressing," the agency said in the Oct. 26...
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.
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.
