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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

FDA website and logo
FDLI Annual Meeting

Recent FDA activity hints at impending commercial speech enforcement

May 17, 2024
By Mark McCarty
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.
Read More
Pills, syringes, financial charts

Economics cited as a driver of worsening drug, device shortages

May 17, 2024
By Mark McCarty
The U.S. FDA is not the only regulatory agency attempting to deal with impending and existing device and drug shortages, although some of the drivers of these shortages are not within these agencies’ purview.
Read More
FDA website and logo
FDLI Annual Meeting

Recent FDA activity hints at impending commercial speech enforcement

May 17, 2024
By Mark McCarty
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.
Read More
Pills, syringes, financial charts

Economics cited as a driver of worsening drug, device shortages

May 16, 2024
By Mark McCarty
The U.S. FDA is not the only regulatory agency attempting to deal with impending and existing device and drug shortages, although some of the drivers of these shortages are not within these agencies’ purview. The FDA’s Jacqueline Corrigan-Curay told an audience here in Washington that the poor payment rates offered by payers for generic drugs are a significant contributor, adding that there are instances in which the per-dose rate paid for one of these generics is less than the typical charge for a cup of coffee.
Read More
Cyber eye illustration
FDLI Annual Meeting

US legislation for AI described as ‘long-term process’

May 15, 2024
By Mark McCarty
Artificial intelligence recently roiled the regulatory world, but the U.S. Congress has yet to dive into the task of legislating on the concept. Barrett Tenbarge, general counsel for Sen. Bill Cassidy (R-La.) told an audience here in the nation’s capital that while the Senate is considering several legislative proposals, the desire to avoid legislation that will create as many problems as it solves suggest that legislative development “is a long-term process.”
Read More
Chanelle Case Borden pipetting DNA samples into a tube for polymerase chain reaction.
FDLI Annual Meeting

FDA’s Califf calls on labs to ‘wake up and develop better tests’

May 15, 2024
By Mark McCarty
The U.S. FDA’s final rule for regulation of lab-developed tests promises to remain controversial for the foreseeable future, but FDA commissioner Robert Califf said that many of these tests have been shown to be less than adequately reliable. Califf said that one of the effects of the final rule is that it will force clinical labs to “wake up and develop better tests,” if only because compliance and enforcement regimes will soon be applied to clinical labs.
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FDA icons and doctor

FDA’s Shuren says resource issues stand in way of expectations

May 14, 2024
By Mark McCarty
The FDA’s Jeff Shuren appeared on a May 14 webinar to discuss operations at the Center for Devices and Radiological Health (CDRH), but he had some choice words for what he suggested is a widespread do-more-with-less mentality. Shuren said that expectations of CDRH’s capacity are in defiance of what he suggested is a modest volume of revenues the center receives each year, a predicament he said demonstrates that “a lot of people are running around stupid” about the realities at the FDA’s device center.
Read More
Cue Care Antiviral

Cue Health hit with FDA warning for changes to COVID EUA test

May 14, 2024
By Mark McCarty
The U.S. FDA issued a May 9 warning letter to Cue Health Inc., of San Diego, following what may have been a routine inspection, but the inspection disclosed that the company had made changes to a COVID test that was granted market access via the emergency use authorization program.
Read More
Magnifying glass, FDA concept image

Bioptimal hit with US FDA warning for uncleared changes to catheters

May 13, 2024
By Mark McCarty
The U.S. FDA has taken off the gloves when it comes to device warning letters. One recent example is the April 3 warning letter to Bioptimal International Ltd., of Shenzen, China, which did not score well with the agency on routine good manufacturing practices. Perhaps more conspicuous was that the company was selling catheters that had undergone significant changes without a new regulatory filing – a seemingly common theme in recent FDA device warning letters.
Read More
Product recall concept image

Route 92 Medical microcatheter recall due to contract manufacturer

May 13, 2024
By Mark McCarty
Route 92 Medical Inc., of San Mateo, Calif., reported a class I recall of nearly 1,000 microcatheters because of reports of separation of the distal tip of the catheter, which is associated with two injuries and one reported death. The company indicated that the problematic catheters had been manufactured by an unidentified contract supplier, once again highlightingthe hazards of a failure to properly oversee the contract manufacture of critical medical devices.
Read More
View All Articles by Mark McCarty

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