Robinson Bradshaw

Topic: CDRH

Weekly Roundup: FDA Regulations, Science Funding and Newborn Screening

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of […]

The FDA and DTC: Time to Set the Record Straight

Earlier this month an FDA advisory panel met for two days to consider a range of issues pertaining to clinical direct-to-consumer (DTC) genetic testing. The non-voting advisory panel’s discussion (pdf), including whether certain genetic tests or categories of tests should be made available only through qualified healthcare professionals, sparked considerable controversy (see here for a […]

The FDA and DTC Genetic Testing: Setting the Record Straight

Earlier this week, I attended a public two-day meeting of the FDA’s Molecular and Clinical Genetics Panel (“MCGP”) in Gaithersburg, MD.  The meeting was not particularly well attended (approximately 100 people were in the room) but the topic of the panel’s deliberations – how to appropriately regulate direct-to-consumer (DTC) genetic tests – has sparked intense […]

The Past, Present and Future of DTC Genetic Testing Regulation

[Editor’s Note: Newsweek science editor Mary Carmichael has a DNA Dilemma. As Carmichael debates whether to take a direct-to-consumer (DTC) genetic test, she is soliciting feedback from the DTC community, from the public and from other commentators, including myself. At the end of the week, she will make her decision. On Tuesday, Carmichael and five […]

“From Gulf Oil to Snake Oil”: Congress Takes Aim at DTC Genetic Testing

It has been a busy week in Washington for direct-to-consumer (DTC) genetic testing companies. Following public FDA meetings and a new round of FDA device notification letters earlier in the week, representatives from three major DTC genetic testing companies (23andMe, Navigenics and Pathway Genomics) were hauled in front of Congress today to defend their companies, their […]

The Conversation Continues: Recap from Day Two of FDA’s Regulatory Meeting

The second and final day of the FDA’s “Public Meeting on Oversight of Laboratory Developed Tests” (LDTs) brought forth many of the same comments and themes as the first. The primary difference was that, whereas the first day began with some comments from the Agency that provided a few hints about what the FDA has […]

The Conversation Begins: Recap from Day One of FDA’s LDT Regulatory Meeting

Welcome to Hyattsville, MD, where we have just completed day one of FDA’s two day “Public Meeting on Oversight of Laboratory Developed Tests” (LDTs). The session was civil, well-organized and largely devoid of surprises. It did, however, mark the official kick-off of the FDA’s highly publicized decision to develop a “risk-based application of oversight” for all […]