News
Podcast: Talking the cure
11 April 2024
Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...
Publications
News
FDA and OHRP publish draft guidance on facilitating understanding in informed consent
11 March 2024
As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research...
News
Device makers must verify third-party lab data, FDA warns
26 February 2024
On Tuesday, the U.S. Food and Drug Administration (FDA) issued a letter warning medical device manufacturers and sponsors of device studies to carefully evaluate the third parties that they ...
News
FDA webinar on speedy LDT rule finalization leaves key questions unanswered
14 December 2023
The U.S. Food and Drug Administration (FDA) signaled that it intends to finalize its laboratory developed test (LDT) proposed rule by April 2024. The new rule (if finalized as...
News
FDA proposal classifying wound dressings/washes with antimicrobials may require PMAs, new 510(k)s
07 December 2023
Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing...
News
Post-COVID, FDA still permits changes to non-invasive remote monitoring devices without 510(k)
23 October 2023
The U.S. Food and Drug Administration (FDA) has revised its guidance on non-invasive remote monitoring devices used to support at-home patient monitoring, replacing its March 2020 guidance...
News
FDA seeks greater LDT oversight and enforcement discretion phaseout by 2028
05 October 2023
In a landmark proposed rule published Friday, the U.S. Food and Drug Administration (FDA) announced plans to make explicit that in vitro diagnostic products (IVDs), including in cases where ...
News
U.S. FDA: labeling guidance for sponsors incorporating prescription drug use-related software
05 October 2023
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which...
News
FDA seeks greater LDT oversight and enforcement discretion phaseout by 2028
04 October 2023
In a landmark proposed rule published Friday, the U.S. Food and Drug Administration (FDA) announced plans to make explicit that in vitro diagnostic products (IVDs), including in cases where ...
