The U.S. FDA has issued an action plan for regulation of artificial intelligence and machine learning (AI, ML), which includes issuance of a draft guidance for change control for adaptive algorithms. There is no guarantee a final guidance will emerge before 2022, however, leaving developers with another year – perhaps longer – of uncertainty as to how to handle change control for their algorithms.
With so much ire in Congress directed toward U.S. prescription drug prices in 2019, it’s not surprising that prices remained relatively stable that year. That’s not to say there weren’t price hikes. In its second report on unsupported price increases, the Institute for Clinical and Economic Review (ICER) identified nine of the 100 top-selling drugs that had list price increases more than double the rate of medical inflation in 2019 and that accounted for the largest increases in U.S. spending on drugs.
Pharmaceutical pain management has aided billions of patients, but has also created millions of cases of addiction, a problem that is driving research into pain. Omowunmi Sadik of the New Jersey Institutes of Technology, said on a recent webinar that the Biosensor Materials for Advanced Research & Technology (BioSMART) Center, is working on a suite of biosensors that may aid in the detection of the molecular markers associated with pain.
Despite a circuit split on the issue, the U.S. Supreme Court Dec. 11 rejected an appeal by Bristol Myers Squibb Co. (BMS) and Sanofi SA over giving states a “second bite at the apple” in whistleblower cases.
Computer system validation (CSV) has been the source of considerable drag on device makers’ efforts to realize value derived from investments in the company’s technology base, but this long-standing issue is finally drawing some much-needed attention.
The U.S. FDA’s safer technologies program, or STeP, is designed in part as a complement to the breakthrough devices program, but the September 2019 draft guidance lent little clarity as to what might constitute a significantly safer device. The Jan. 5, 2021, final guidance does little to clarify that question, however.
Emboline Inc., which is developing technology to reduce the chance of stroke during transcatheter heart procedures, completed a $10 million series C financing. The funds are earmarked to gain initial commercial approval of the company’s Emboliner device and to launch a U.S. pivotal study. The round, which included new and existing investors, follows a $5 million bridge round of financing that closed last January.
A New Year tradition in the U.S. is the inevitable price increase for a multitude of brand drugs. 2021 isn’t breaking with that tradition, despite American families being ravaged economically by nearly a year of the COVID-19 pandemic.
The U.S. FDA’s device center may still be grappling with the COVID-19 pandemic throughout the remainder of fiscal year 2021, but that does not mean other considerations have disappeared. The FDA’s Erin Keith said the agency will keep working on a major overhaul of the quality systems regulation (QSR) but will also work toward expanding industry’s use of advanced manufacturing technologies, such as additive manufacturing.
The U.S. Department of Health and Human Services (HHS) released an advisory opinion last week saying that drug manufacturers are obligated to provide 340B pricing for outpatient drugs dispensed by contract pharmacies on behalf of hospitals and clinics that qualify for the discounts. But the opinion said nothing about enforcement action or assessing civil penalties against manufacturers who refuse to do so.
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