In this week’s news, diagnostics and device changes at the US FDA, UK Government details no-deal drug regulation plan and more…
US FDA wants streamlined reviews for diagnostic tests
The US FDA wants to change how tests used to diagnose disease and identify patients likely to benefit from certain drugs are regulated says Commissioner Scott Gottlieb.
Gottlieb shared details last Thursday.
According to RAPS, the commissioner sees a future in which 50 percent of tests are exempt from premarket review, 10 percent require assessment and the remaining 40 percent would be eligible for a precertification pathway.
He said “As clinical testing gets more and more sophisticated, we need to make certain that we have the right regulatory framework in place to ensure that these new clinical tests—including ones that we cannot even envision today—are accurate, reliable, and safe.”
“Under this framework, all in vitro clinical tests would fall under a unified set of requirements that would also exempt from pre-market review many categories of new or subsequently-modified tests. This would include manual tests, tests for rare disease, and low-risk and low-volume diagnostics,” he said.
US FDA rejigs rules on voluntary malfunction reporting for medical device firms
In other news, the FDA will let manufacturers voluntarily report non-critical device malfunctions on a quarterly basis to streamline the review process.
The regulator outlined the plan in the Federal Register, explaining that, if they choose to, device manufacturers can report malfunctions in a summary each quarter rather than individually in 30-day malfunction reports.
FDA Commissioner Scott Gotlieb said the approach is designed to streamline reporting and allow the agency to make better use of resources.
For certain devices reporting guidelines will not change. For example, if the malfunction results in death or serious injury the manufacturer is required to notify the agency using established processes.
Read more at InsideMedicalDevices.
UK promises streamlined drug regulations after Brexit
The UK Government claims rules governing the production, importation and use of drugs will be simplified in the result of a no-deal Brexit.
The Government made the claim in a document published on Friday in which it also outlined how the MHRA will review new drugs and oversee existing products after the UK leaves the bloc.
It wrote, “After EU Exit, to market a product in the UK, an initial MA application will need to be submitted to the MHRA and will go through a national assessment.
“MHRA will take a streamlined approach to approving UKMA applications that places no greater burden on industry and ensures that patients can access new and innovative medicines at the same time as EU patients.
“The UK will no longer be a part of the EU centralised, mutual recognition and decentralised procedures.”
Whether the MHRA would be able to fulfil the role is a subject of considerable debate.
Professor Sir John Bell, lead author of the Life Sciences Sector Deal recently told PMLive the agency has sufficient capacity and expertise, particularly in the regulation of advance medical products.
In contrast, while neither organization has raised concerns about the MHRA, both the ABPI and BIA have stated their preference for a deal with the EU in which the UK’s regulator retains associate membership of the EMA.
Also in the news
The EMA has published a multilingual guide on biosimilars, designed to encourage their use in the European Union. See details here.
Contract API manufacturer Fabbrica Italiana Sintetici has asked engineering firm Emerson to automate production at three of its facilities in Italy. Read more at Manufacturing Chemist.
US president Donald Trump’s ongoing efforts to reduce drug prices may involve changes to rules surrounding the activities of pharmacy benefit managers according to a Bloomberg report.
Dyadic says industry demand for alternatives to CHO cell lines is growing, citing Sanofi deal as an example. Read more at Bioprocess Insider.
An editorial in the New York Times looks at success rate in ‘precision medicine.’