Ferdous Al

This week, the New York Times published an article scrutinizing potential instances of conflict of interest by FDA@s former device chief Jeff Shuren, FDA authorized updated COVID-19 vaccines ahead of the fall immunization campaign, and FDA issued its much-anticipated draft guidance on pre-determined change control plans (PCCPs).

The European Commission has proposed updating common specifications for certain class D in vitro diagnostic devices to consider tests for certain parasites and viruses that are of public health concern. Stakeholders have four weeks to comment on the proposed amendments.

Stakeholders want more transparency and clarity on how the US Food and Drug Administration (FDA) conducts meetings with drug and biologics sponsors. They also want the agency to provide its rationale when certain aspects of their meeting requests are denied, including requests for in-person and virtual meetings. @

The US Food and Drug Administration (FDA) has finalized guidance on submitting voluntary malfunction summary reports for certain class I and class II lower-risk devices. The guidance is almost identical to the draft version but includes several report samples for manufacturers to reference.

The US Food and Drug Administration (FDA) has sent four warning letters to companies for selling continuous positive airway pressure (CPAP) machine cleaners online without proper marketing authorization. @

Stakeholders want the US Food and Drug Administration (FDA) to provide more detail about its information technology and user experience strategies. They would also like to see a more centralized approach to implementing the strategies to avoid duplicative or incompatible efforts by the agency@s product centers.

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance that would significantly revise its previous guidance on using voluntary patient preference information (PPI) for medical devices, shifting its focus from the premarket phase to incorporating PPI across the total product life cycle. @

Welcome to another installment of This Week at FDA, your weekly source for updates @ big and small @ on FDA, drug, and medical device regulation, and what we@re reading from around the web. This week, the Associated Press reported FDA is struggling to complete a backlog of drug facility inspections, and the agency said it will investigate reports of toxic metals in tampons after being pressed on the issue by Democratic lawmakers.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed to a set of guiding principles for their staff when using large language models (LLM) to make regulatory decisions. Artificial intelligence (AI) virtual assistants or chatbots use LLMs to formulate results, and the agencies foresee regulators using such technology in their work.

Stakeholders want the US Food and Drug Administration (FDA) to give them even more leeway in responding to misinformation about their products. Some of the proposed changes include looking beyond enforcement discretion and online communications, addressing how artificial intelligence (AI) aggregation may affect misinformation, and dealing with people impersonating a company or its officials.