The U.S. FDA raised some hackles with its final guidance for clinical decision support (CDS) software, thanks to provisions that some stakeholders argued flew against congressional intent regarding the regulatory status of some device functions. That final guidance is now the target of a petition by the CDS Coalition to withdraw and rewrite the final guidance, arguing that the agency is “doing an end run” around the limitations established by Congress regarding the FDA’s oversight of software as a medical device (SaMD).
The U.S. International Trade Commission (USITC) is launching an investigation into the importation from China of certain thyroid hormone receptor-beta agonists, products containing them and the manufacturing processes being used.
A federal court cut off efforts Feb. 6 to halt a U.S. program allowing prescription drug imports from Canada before the program gets off the ground. The U.S. District Court for the District of Columbia dismissed a suit by the Pharmaceutical Research and Manufacturers of America (PhRMA) and other organizations, saying that they lacked standing because neither they nor their members face “a concrete risk of harm from the inchoate importation program.”
While the new inflation-based rebate on certain Part B drugs may generate billions of dollars in savings for Medicare, implementing the rebate could be more challenging than the U.S. Congress and the Biden administration expected when the Inflation Reduction Act was enacted last August.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Awakn, Astrazeneca, CSL Vifor, FSD, Kiora, Optimi, Pharmather, Rocket.
The U.S. FDA and makers of medical devices have several collaborative programs, but the two sides have joined forces yet again in a new collaboration, this time to address both product quality issues and supply chain resiliency.
The Medical Device Innovation Consortium (MDIC) has played a key role in fostering a stronger industrial appreciation for the need for robust cybersecurity, but a recent MDIC report noted that many device makers are deficient in pushing cybersecurity considerations into the domain of design controls. However, the most critical element in cybersecurity may be whether a company has a chief product security officer (CPSO), the presence of absence of which seems to correlate strongly and uniformly with all aspects of cybersecurity in a manufacturer’s products.
Cardiorenal Systems Inc. has scored a U.S. FDA breakthrough device designation for technology to prevent patients undergoing cardiac surgery from developing acute kidney injury (AKI). AKI is reported in up to 30% of approximately 780,000 cardiac surgeries performed each year in the U.S., Europe and the Middle East, complicating patient recovery, prolonging ICU hospitalization and contributing to patient mortality after surgery.
Beginning July 1, Australia’s Therapeutic Goods Administration will allow medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for certain mental health conditions.
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