BioWorld - Thursday, January 15, 2026

Articles by Mark McCarty

FDA icons and doctor

FDA advisory panel says no to test for opioid use disorder

Oct. 27, 2022
By Mark McCarty
A U.S. FDA advisory panel saw a number of problems in the clinical trial for the Avertd test for opioid use disorder (OUD), including the fact that the study failed to enroll a sufficiently ethnically diverse body of subjects. Perhaps more damning was that the advisory panel was uncertain as to whether the 15 single nucleotide polymorphisms (SNPs) evaluated in the test were helpful in sorting out which patients were truly at high risk of OUD, leading to an 11-2 vote that the probable benefits of the test do not outweigh the risks.
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FDA approved icons and medical professional
2022 Medtech Conference

Shuren floats voluntary alternative pathway for digital device premarket review

Oct. 27, 2022
By Mark McCarty
Innovative medical devices are the norm for reviewers at the U.S. FDA’s Center for Devices and Radiological Health (CDRH), but regulatory innovation is a tougher climb. In response, CDRH director Jeff Shuren said at this year’s Medtech Conference in Boston that the agency is eyeing a voluntary alternative pathway (VAP) for novel digital technologies, although this concept is unlikely to see the regulatory light of day other than as a pilot program at any point in the next year or two, given the need for statutory authorization.
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2022 Medtech Conference

Recent case law suggests a need to take care in use of consultant physicians

Oct. 25, 2022
By Mark McCarty
Device makers often need the assistance of physicians to aid in device design and development, but this is a practice that comes with some legal hazards. A session held here in Boston on enforcement in the U.S. made clear that manufacturers must exercise caution in these consulting arrangements, such as documenting the need for outside help with the device, lest the manufacturer end up with a hefty, multimillion-dollar fine imposed by U.S. enforcement agencies.
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2022 Medtech Conference

Torres says regulatory alignment a pressing consideration for AI change control draft

Oct. 24, 2022
By Mark McCarty
The U.S. FDA recently released its guidance agenda for fiscal 2023, a plan that de-emphasizes the oft-promised draft guidance for change control for artificial intelligence (AI) algorithms, which is listed as a B priority instead of an A draft guidance priority. At this year’s Medtech Conference here in Boston, the FDA’s Melissa Torres disavowed the notion that any national regulatory authority is delaying another authority’s policy on software change control, but she acknowledged that these conversations about regulatory harmonization typically predate formal policy development.
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Gavel and First Amendment
FDLI Advertising and Promotional Conference

Supreme Court may provide new vectors for commercial speech enforcement

Oct. 14, 2022
By Mark McCarty
The U.S. FDA’s regulation of commercial speech under the First Amendment has been controversial and has handed the agency several losses in court, but Arun Rao of the U.S. Department of Justice let it be known that DOJ is still keen on commercial speech enforcement. Rao said the case of Gonzalez v. Google, which will be heard by the Supreme Court, is an example of potentially precedent-setting litigation, and that manufacturers of drugs and devices may experience an uptick in enforcement depending on where the Supreme Court lands in Gonzalez.
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U.S. Capitol building, Washington D.C.

Advamed says FDA may act on LDT regulation if VALID Act fails again

Oct. 14, 2022
By Mark McCarty
The Verifying Accurate Leading-edge IVCT Development (VALID) Act has been floating around Capitol Hill for the past four years, but was once again left by the wayside when Congress passed the latest round of U.S. FDA user fee legislation. Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said in a press briefing that the prospects for the legislation dim considerably if Congress does not pass the VALID Act by the end of the calendar year, raising the prospect that the FDA will act unilaterally to engage in rulemaking to deal with regulation of lab-developed tests.
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FDLI Advertising and Promotional Conference

Supreme Court may provide new vectors for commercial speech enforcement

Oct. 13, 2022
By Mark McCarty
The U.S. FDA’s regulation of commercial speech under the First Amendment has been controversial and has handed the agency several losses in court, but Arun Rao of the U.S. Department of Justice (DOJ) let it be known that DOJ is still keen on commercial speech enforcement. Rao said the case of Gonzalez v. Google, which will be heard by the Supreme Court, is an example of potentially precedent-setting litigation, and that manufacturers of drugs and devices may experience an uptick in enforcement depending on where the Supreme Court lands in Gonzalez.
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Abbott, other stakeholders seek expanded coverage for continuous glucose monitors

Oct. 12, 2022
By Mark McCarty
Two Medicare administrative contractors are examining a request for expanded Medicare coverage of continuous glucose monitors (CGMs) that would drop the requirement that patients routinely administer insulin at least three times a day. The requestors, Alameda, Calif.-based Abbott Diabetes Care Inc., and a group of stakeholders including the Juvenile Diabetes Research Foundation (JDRF), assert that such a change is not only endorsed by two medical societies, but is also supported by clinical evidence, and the net effect for industry may be to significantly accelerate sales of these devices.
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