Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.
Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.
Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.
A June 25 hearing in the U.S. House of Representatives highlighted some of the health care spending benefits of remote patient monitoring, but Medicare payment is seen as deficient – a problem that may be resolved by pending legislation.
According to a new listing at the FDA device recalls and alerts webpage, Dublin-based Medtronic plc., requested customers quarantine any Bravo CF capsules, an esophageal pH monitoring system.
Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.
The Department of Health and Human Services and private payers have promised to streamline the controversial prior authorization processes in a bid to reduce the attendant controversies.
The Medicare Payment Advisory Commission advised Congress that inflation is taking a bite out of physician pay and Medicare payments may have to increase in order to preserve patient access to care.
The U.K. Medicines and Healthcare Products Regulatory Agency opened a second round in its AI airlock program although this round, like the first round, will be limited to four applicants.
The U.S. Centers for Medicare & Medicaid Services finalized a coverage policy for at-home ventilation for patients with chronic respiratory failure. The amended policy also establishes a series of criteria for coverage of ventilation for chronic obstructive pulmonary disease.
