In this week’s news, the US FDA’s device plans raise concerns, calls for greater ethnic diversity in trials, revisions to outsourcing compounder oversight and more…
Those in favour say AI, but the device industry not so much
Pharma groups have raised concerns about US FDA plans to regulate AI and Machine Learning software in medical devices.
The US regulator suggested it could use risk-based, “focused reviews” to conduct premarket assessments of devices that use adaptive AI and ML software in April.
Scott Gottlieb, agency Commissioner at the time, contrasted the proposed approach with how “locked” software in older devices is regulated.
“For traditional software as a medical device, when modifications are made that could significantly affect the safety or effectiveness of the device, a sponsor must make a submission demonstrating the safety and effectiveness of the modifications.
“With artificial intelligence, because the device evolves based on what it learns while it’s in real world use, we’re working to develop an appropriate framework that allows the software to evolve in ways to improve its performance while ensuring that changes meet our gold standard for safety and effectiveness throughout the product’s lifecycle—from premarket design throughout the device’s use on the market.”
Several groups took issue with the proposed reliance on regulatory proposals that are untested or still under development, citing the proposed good manufacturing learning practices (GMLPs) as an example.
FDA rejigs oversight of drug compounders
In other news, the US FDA says it plans to reorganize its oversight of drug compounders.
According to RAPS, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) announced agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.
Woodcock added, “Within the Office of Compliance, a new compounding team has been established within the Immediate Office with responsibility for overall management of the program.”
Compounding has been a concern for the FDA since 2012 when an outbreak of meningitis that resulted in 60 deaths was linked to drugs made by the New England Compounding Center.
US pushes for diversity in clinical trials
Another development at the FDA this week has seen the agency outline how pharmaceutical developers can improve ethnic diversity in clinical trials.
In a draft guidance document released on Thursday the FDA said the aim is to encourage drug firms to enrol patients that more closely reflect the populations that will take the drugs in the real world.
According to the FDA “This guidance recommends approaches that sponsors of clinical trials to support a new drug application [NDA] or a biologics license application [BLA] can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrolment of underrepresented populations in their clinical trials.”
Also in the news
RAPS looked at the role industry groups can play in helping to shape regulatory policy.
Companies thinking of adopting continuous manufacturing processes may need to rethink their viral safety strategies according to experts interviewed by GEN.
Biopharmadive reported comments made by Janet Woodcock at BIO. Woodcock was speaking about biosimilar approvals and changes to how clinical trials are regulated in recent years.
Health Canada has outlined when off label use of medicines is not considered to be investigational in a clinical trial.
Developments in the CDMO space
Cambrex has finished work on its new process development and analytical services facility in Sweden. See press release here.
Contract Pharmacal has announced the acquisition of Florida Pharmaceutical Products. According to a report in Contract Pharma the deal builds Contract Pharmacal’s presence in the generics sector.
Fujifilm Diosynth has established a fully integrated continuous production system at its site in the UK. See announcement here.