Implementation of the new regulations for medical devices and in vitro diagnostics in the EU have presented a number of problems, including a serious crunch in the availability of notified bodies (NBs) to review premarket filings.
No one denies that fewer new drugs will be a consequence of the Medicare drug pricing provisions the Democrats are trying to push through the U.S. Congress ahead of the midterm election campaign season. Less attention has been paid to the negative impact on drug-device combinations and new diagnostics that accompany innovative treatments.
The controversies over the use of ethylene oxide (EtO) as a medical device sterilant were quelled by the COVID-19 pandemic, but the U.S. Environmental Protection Agency (EPA) has resurrected the issue.
The U.S. FDA’s guidance for unique device identifiers (UDIs) is heavily adjusted to account for a device’s inherent risk class, and many class I devices are now going to enjoy another reprieve from UDI requirements per an updated FDA guidance.
Smiths Medical Inc., of Minneapolis, has undertaken a recall of its Medfusion 3500 and 4000 series of syringe infusion pumps because of software issues that could lead to over- or under-infusion of the drug. The U.S. FDA said the devices swept up in this class I recall are associated with seven serious injuries and one fatality, although the manufacturer indicated that a software update is in the works.
Illumina Inc.’s acquisition of Grail Inc., of Menlo Park, Calif., may or may not prove to be a case of jumping the regulatory gun, but the move to date has not racked up significant financial penalties for the company. That may soon change per a statement by the European Commission, which said that Illumina may find itself on the receiving end of “hefty fines,” a statement made by EC executive vice president Margrethe Vestager.
Amid the ongoing war Russia is waging in Ukraine, representatives of several Western biopharma and medical device companies met with Russian health officials this week to discuss an uninterrupted drug supply, maintenance of medical equipment in Russia and software updates. Russian Minister of Health Mikhail Murashko told the group his agency’s top priority is an uninterrupted drug supply. He recognized that dialogue between the government and manufacturers is necessary to maintain that supply.
Amid the ongoing war Russia is waging in Ukraine, representatives of several Western biopharma and medical device companies met with Russian health officials this week to discuss an uninterrupted drug supply, maintenance of medical equipment in Russia and software updates. Russian Minister of Health Mikhail Murashko told the group his agency’s top priority is an uninterrupted drug supply. He recognized that dialogue between the government and manufacturers is necessary to maintain that supply.
Amid the ongoing war Russia is waging in Ukraine, representatives of several Western biopharma and medical device companies met with Russian health officials this week to discuss an uninterrupted drug supply, maintenance of medical equipment in Russia and software updates.
Providing faster and better access to new medicines is the driving force behind a two-year proof-of-concept pilot program the EMA plans to launch in September.
