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Home » Topics » Regulatory

Regulatory
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FDA sign

Quick approval of ’UFAs needed to secure US FDA funding

Feb. 3, 2022
By Mari Serebrov
The process of reauthorizing critical U.S. FDA user fee agreements (UFAs) for drugs, generics and biosimilars took its first step forward in Congress Feb. 3 as the House Energy & Commerce Subcommittee on Health dipped its feet into the new enhancements included in the agreements the FDA negotiated with stakeholders over the past two years.
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Regulatory actions for Feb. 3, 2022

Feb. 3, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Jazz, Logicbio, Pfizer, Qsam, Samsung, Theseus.
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Flag of the Russian Federation

Russia preparing for WHO accreditation

Feb. 2, 2022
By Mari Serebrov
Russia’s Ministry of Health is looking to extend its role on the global stage. Over the next few months, the ministry, along with other regulatory agencies in Russia, said it plans to start the accreditation process of coming into compliance with World Health Organization (WHO) standards.
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Regulatory actions for Feb. 2, 2022

Feb. 2, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivecor, Vyspine.
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Pandemic lessons fuel reignition of US cancer moonshot

Feb. 2, 2022
By Mari Serebrov
Since COVID-19 hit the U.S. in 2020, the pandemic has taken more than 800,000 American lives. In that same time, cancer has claimed 1.2 million lives, President Joe Biden said Feb. 2 as he “reignited” the cancer moonshot he first launched in 2016 when he was serving as vice president.
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US FDA begins review of vaccine for youngest Americans

Feb. 2, 2022
By Mari Serebrov
Amid pressure to get a COVID-19 vaccine authorized for infants and toddlers sooner than later, Pfizer Inc. and Biontech SE initiated a rolling submission seeking to amend the U.S. FDA’s emergency use authorization for their mRNA vaccine to include children 6 months through 4 years of age.
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Doctor signaling timeout

Logicbio study placed on clinical hold due to two SAEs in children

Feb. 2, 2022
By Lee Landenberger
The FDA has placed Logicbio Therapeutics Inc.’s phase I/II clinical trial of LB-001, an investigational AAV genome-editing therapy for treating pediatric patients with methylmalonic acidemia (MMA), on a clinical hold. So far, four patients have been dosed in the study and two have had serious adverse events related to the candidate, the company’s lead asset.
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Regulatory actions for Feb. 2, 2022

Feb. 2, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Azafaros, Brand Institute, Denovo, Immune-Onc, Janssen, Moderna, Mydecine, Ose, Pharmather, Veloxis, Viiv.
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Intra-op image of incision with the inserted Inspan ISP device

FDA-cleared spinal stenosis device aimed squarely at interventional pain physicians

Feb. 1, 2022
By David Godkin
Inspan LLC has won FDA 510(k) clearance for an interspinous fixation system that can now be used to treat lumbar spinal stenosis in non-cervical spine cases of spondylolisthesis, trauma, tumor and degenerative disc disease. According to Aditya Humad, co-founder and CFO of Kicventures Group which counts Inspan among its portfolio companies, FDA clearance represents an expansion in the use of Inspan’s interspinous system into the “highly competitive space” of interventional pain management.
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Kidneys

Applaud Medical wins FDA breakthrough device designation for urinary stone device

Feb. 1, 2022
By Catherine Longworth
Applaud Medical Inc. has secured breakthrough device designation from the FDA for its acoustic enhancer technology to be used in conjunction with ureteroscopy with laser lithotripsy (URS-LL) for the fragmentation of calcium-based urinary stones. The San Francisco-based company is currently enrolling subjects in an FDA-approved pivotal trial evaluating the technology’s safety and efficacy.
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