With regulatory science always lagging innovation, ambiguity has long been a certainty at the FDA and is likely to become even more so as the pace of new technologies quickens.

The FDA's Center for Drug Evaluation and Research (CDER) issued 62% more warning letters under the first part of the Trump administration than it did during the last few years of the Obama administration. But the number of warnings for medical devices, food and tobacco products fell sharply under President Donald Trump, according to an investigative report being published in the July 5 issue of Science.

In the words of former FDA Commissioner Scott Gottlieb, the five-week government shutdown that ended Jan. 25 was "the most difficult operational challenge we have faced in modern times." While the full impact of that challenge could ripple through the FDA for a while, it made little difference in the number of warning letters the agency sent out between Dec. 23 and Jan. 25.

Approval of Alexion Pharmaceutical Inc.'s Soliris (eculizumab) injection to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive makes it the first and only FDA-approved treatment. It's also one of the most expensive treatments in the world, making it vulnerable to off-label use and the eventual creep of biosimilars into the market.

Cochlear Ltd., of Sydney, received U.S. FDA approval for its Nucleus Profile Plus cochlear implant and the Nucleus 7 sound processor's new built-in connectivity, enabling direct streaming with compatible Android smartphones. The implant will be commercially available in the U.S. later this month.

Netanya, Israel-based Theranica Bioelectronics Ltd., which is focusing on the development of advanced electroceuticals for migraine and other pain disorders, scored a win at the U.S. FDA, with the agency granting its de novo request for the smartphone-controlled Nerivio Migra.

The FDA has granted de novo approval to 23andme Inc. for its report on BRCA1 and BRCA2 risk for developing breast, prostate or ovarian cancer. The direct-to-consumer (DTC) saliva test can provide insight on three genetic mutations linked to the cancers, most commonly found in patients of Eastern European, or Ashkenazi Jewish heritage, which account for a relatively small portion of patients. There are more than 1,000 mutations of the BRCA gene, and the test is not intended to diagnose or rule out the presence of mutation, or increased risk of the particular cancers due to other factors.

Foundation Medicine Inc.'s pan-cancer detection test has received a nod from the FDA, making it one of the most comprehensive companion diagnostics to receive approval from the agency. Concurrent with FDA approval, the Centers for Medicare and Medicaid Services issued a preliminary National Coverage Determination (NCD) for the Foundationone Cdx.

The number 23 is an interesting number. It’s a prime number, and is the number of pairs of chromosomes in human DNA, but it may also become a number FDA won’t soon forget. FDA recently issued a warning letter to 23andMe, ordering the company to stop offering its gene testing service pending further evaluations of the tests. Then a petition popped up at the website for the White House to require FDA to back off. The petitioners argue the agency “grossly overstates the risks” associated with the test, adding that consumers understand those risks. I won’t pretend to know what...

The MedTech Investing Conference held each May in Minneapolis is one of the more interesting investor-focused gatherings on the calendar. It always earns accolades from attendees as representing one of the best opportunities to bring together venture capitalists, entrepreneur/innovators and corporate development types, the latter of whom are always happy to spread the message that they’re open for business. Held for the 12th year earlier this month, the conference offered quite the reminder of the range of emotions being felt these days by those involved with or interested in med-tech. During his welcoming comments, conference co-chairman Kevin Wasserstein, founder and principal...