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Home » Topics » Regulatory

Regulatory
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Empty prescription drug bottle

Regulatory policies – solution or culprit in US drug shortages?

June 14, 2023
By Mari Serebrov
As new and ongoing drug shortages in the U.S. limit patients’ access to essential medicines and life-saving cancer treatments, the blame largely has fallen on increased demand, quality problems, the supply chain and lack of transparency in that chain.
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Regulatory actions for June 14, 2023

June 14, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx, Futura, Gencurix.
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AI silhouette

Medtech Europe, others voice concerns regarding EU’s Artificial Intelligence Act

June 14, 2023
By Mark McCarty
Negotiations over the text of the EU’s Artificial Intelligence Act (AI Act) are drawing to a close, but stakeholders are concerned about several key aspects of the legislation, such as how the term “artificial intelligence” is defined. However, Medtech Europe and other groups, including medical professional societies, are also concerned that the provisions for governance of data would seem to exclude real-world data as a source of evidence, an oversight they say will diminish the utility of AI software in health care.
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US House committee recommends FDA move on rulemaking for LDT regulation

June 14, 2023
By Mark McCarty
The June 14 hearing of the House Appropriations Committee was focused largely on spending levels for the Department of Agriculture, but there was also some concern over the proposed spending levels for the FDA. One of the more conspicuous features of the legislative report is the recommendation that the FDA finalize guidance or rulemaking for risk-based regulation of lab-developed tests (LDTs), a clear departure from the stance taken by Congress for a number of years.
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Surmodics Inc.’s Pounce

FDA 510(k) clears the way for Surmodics to Pounce on expanded thrombectomy opportunity

June 14, 2023
By Annette Boyle
Surmodics Inc. is poised to jump on the market for below the knee thrombectomy now that its Pounce platform with a low-profile (LP) model has FDA 510(k) clearance. The system can now effectively clear organized clots from vessels as small as 2 mm in diameter. The Pounce LP expands the Eden Prairie, Minn.-based company’s “grab-go-flow” platform. In its first iteration, Pounce enabled removal of thrombi and emboli in peripheral arteries 3.5 mm to 6 mm in diameter.
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Prescription drug bottle, pills shaped in $ sign

Blast from the past: Sanders seeks to reinstate ‘reasonable pricing clause’

June 13, 2023
By Mari Serebrov
Using his new platform as chair of the U.S. Senate Health, Education, Labor and Pensions Committee, Sen. Bernie Sanders (I-Vt.) is again pushing the Biden administration to reinstate, and strengthen, a “reasonable pricing clause” in all future research agreements involving government agencies, especially those funding drug R&D.
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Hand holding elbow

China Medical System obtains second psoriasis drug approval in 2023

June 13, 2023
By Doris Yu
China’s NMPA granted a green light to China Medical System Holdings Ltd.’s tildrakizumab injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sold under the brand name Ilumetri, tildrakizumab is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor to block the release of pro-inflammatory cytokines and chemokines.
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Regulatory actions for June 13, 2023

June 13, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neoteryx, Smith & Nephew.
Read More
Rapid testing result for COVID-19

US authorities continue to pursue COVID testing fraud

June 13, 2023
By Mark McCarty
U.S. federal authorities continue to wrap up cases in connection with COVID fraud, the latest of which yielded a $30 million fine for a single defendant accused of fraud and money laundering.
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Democrats, Republicans spar over FDA drug shortage authority in PAHPA reauthorization

June 13, 2023
By Mark McCarty
The need to reauthorize the U.S. Pandemic and All-Hazards Preparedness Act (PAHPA) prompted a June 13 hearing in the House of Representatives, but a major fissure appeared between the Republican and Democratic Parties regarding FDA’s authorities for managing drug shortages.
Read More
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