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Home » Topics » Regulatory

Regulatory
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Coronavirus, lungs, hand holding stethoscope

FDA grants EUA for breath test for COVID, but impact on overall test volume is limited

April 18, 2022
By Mark McCarty
The FDA has granted an emergency use authorization (EUA) to Inspect IR Systems LLC, of Frisco, Texas, for the company’s namesake test that evaluates the patient’s breath for the presence of volatile organic compounds (VOC) indicative of the SARS-CoV-2 virus. The test is expected to increase the volume of testing by only 64,000 per month at the current rate of production, however, making this a technological breakthrough of limited impact on the COVID-19 pandemic.
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Flag of Australia, sky background

Australia’s TGA meets legislated time frames for device, IVD reviews

April 18, 2022
By Tamra Sami
In its first report on device application processing times since it completed most of its medical device reforms, Australia’s Therapeutic Goods Administration (TGA) met all the legislated time frames for processing medical device applications during the six-month period from July 31 to December 2021.
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Regulatory actions for April 18, 2022

April 18, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bendit Technologies, Sonoscape Medical.
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Japanese money and medicine

Japan’s annual drug price reforms result in less predictability for pharma market

April 18, 2022
By Tamra Sami
Japan’s Ministry of Health, Labour and Welfare announced 2022 drug price revisions that became effective on April 1. Across the board, the cuts averaged about 6.6%, which translates to more than ¥600 billion (US$4.73 billion), and the pace of cuts is expected to accelerate. Price cuts in 2021 were worth roughly ¥430 billion.
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Ukoniq

TG Therapeutics rethinks oncology as stock stumbles

April 18, 2022
By Lee Landenberger
A week before the U.S. FDA’s Oncologic Drugs Advisory Committee was to meet and review TG Therapeutics Inc.’s BLA and sNDA for the combo of ublituximab and Ukoniq (umbralisib) for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, the company voluntarily withdrew the submission and now is rethinking its oncology programs. The move was tied to an FDA-requested analysis of phase III data showing that, while study met its primary endpoint, there was an imbalance in updated overall survival (OS) results favoring the control arm. A June 25 PDUFA date had been set for the combination treatment.
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Regulatory actions for April 18, 2022

April 18, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Astellas, Coherus, Innovent, Inxmed, Merck, PTC, Regeneron.
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Hand holding FDA blocks

Not-so-confidential: Trade groups see disclosure risk in FDA device remanufacturing draft

April 14, 2022
By Mark McCarty
The FDA’s June 2021 draft guidance for remanufacturing of medical devices wades into a highly complicated area of compliance for third-party servicing organizations that may not be familiar with FDA regulations, but the draft has sparked another set of concerns. Two trade associations said the draft would seem to suggest that original equipment manufacturers (OEMs) must disclose confidential trade secrets to give these third parties the information needed to service these devices, a suggestion that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (AdvaMed) said is clearly out of bounds.
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FDA adds orthopedic fracture fixation plates to device types eligible for 510(k) alternative

April 14, 2022
By Mark McCarty
The U.S. FDA’s safety and performance-based pathway (SPBP) is intended as a leaner, meaner alternative to the conventional 510(k) pathway that would sidestep some of the presumed problems with the concept of substantial equivalence. The agency recently added four device types to this program, including orthopedic fracture fixation plates.
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Regulatory actions for April 14, 2022

April 14, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fosun Diagnostics.
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China clarifies regulations on sharing human genetic resources

April 14, 2022
By Tamra Sami
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
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