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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

Regulatory icons

US PTO peels back 2022 memo on discretionary denials of IPRs

March 3, 2025
By Mark McCarty
The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews.
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Tug-of-war illustration

Novelty of PCCP filings a source of drag for FDA, industry

Feb. 28, 2025
By Mark McCarty
Nick Decker, directory of global regulatory policy for Roch Holding AG’s Roche Diagnostics division, said the FDA is moving carefully into the PCCP space, and industry, too, is taking a measured approach in adopting the PCCP concept.
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Woman holding display of business, regulatory icons

Little interest shown in premarket use of MDSAP audits

Feb. 27, 2025
By Mark McCarty
A number of regulatory agencies have signed on to the Medical Device Single Audit Program (MDSAP) for postmarket uses, but the U.S, FDA cannot use these audits for premarket purposes.
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U.S. Supreme Court

Loper Bright no free pass where FDA’s LDT rule is concerned

Feb. 26, 2025
By Mark McCarty
The FDA’s final rule for lab-developed tests (LDTs) is in litigation, and a district court decision may be shortly in the works.
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U.S. Capitol building, Washington D.C.

FDA’s LDT rule, CDS guidance combine to complicate regulatory life

Feb. 26, 2025
By Mark McCarty
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.
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U.S. flag on columned building

Federal Circuit reassigns patent case over impatient district judge​

Feb. 14, 2025
By Mark McCarty
The U.S. Court of Appeals for the Federal Circuit occasionally remands a patent litigation case to district court for a variety of reasons, as seen in a decision involving Trudell Medical and D R Burton.
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United Kingdom flag, map

​MHRA sets up pilot program for real-world evidence​

Feb. 13, 2025
By Mark McCarty
The U.K. Medicines and Health Care Products Regulatory Agency reported a pilot program for the use of RWE in regulatory decision making, which is largely directed toward drug products.
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European Union flag with wooden gavel

EC drops AI liability directive for now

Feb. 12, 2025
By Mark McCarty
The European Commission’s proposal for an AI-specific liability law seemed destined to pile onto existing EU liability law, but the commission reported it will pull the legislative proposal dubbed the AI Liability Directive.
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3D rendering showing osteoporosis in the femur

US task force tweaks osteoporosis screening recommendations

Feb. 12, 2025
By Mark McCarty
The U.S. Preventive Services Task Force updated a 2018 series of recommendations for screening for osteoporosis, but the update has its detractors.
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Artificial intelligence and digital health icons

European Commission provides guidance for AI Act

Feb. 11, 2025
By Mark McCarty
The European Commission issued a set of guidelines for the use of AI as a supplement to the EU’s Artificial Intelligence Act, a document of which chatbot developers will want to take note.
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View All Articles by Mark McCarty

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