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Home » Topics » Regulatory

Regulatory
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MHRA adds to capacity for review of in vitro diagnostics

Jan. 20, 2023
By Mark McCarty
Bringing notified bodies (NBs) into a med-tech regulatory system has proven to be no mean feat in the European Union, but the U.K. Medicines and Health Care Products Regulatory Agency (MHRA) seems not to suffer from such impediments. The agency just added several in vitro diagnostic (IVD) technological areas to the roster of tests that can be reviewed by UL International UK, an addition that will help ensure patients can obtain the tests they need.
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Selux

FDA can’t resist Selux rapid antibiotic susceptibility testing platform

Jan. 20, 2023
By Annette Boyle
Selux Diagnostics Inc. received U.S. FDA 510(k) clearance for its next generation phenotyping (NGP) system, a rapid antibiotic susceptibility test (AST) platform that determines a bacteria’s susceptibility to 14 specific antimicrobial agents in less than six hours. Prompt identification of the narrowest effective antimicrobial for an infection is critical to the battle to preserve the efficacy of critical antibiotics and slow the development of ‘superbug’ infections.
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India drug regulations under the scanner again after fresh WHO alert on contaminated cough syrup

Jan. 20, 2023
By T.V. Padma
India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country, varieties of which have led to the deaths of scores of children in late 2022.
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IV drips

FDA lifts clinical hold on Astellas Fortis AAV gene therapy trial in Pompe disease

Jan. 20, 2023
By Tamra Sami
The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating adeno-associated virus (AAV) gene replacement therapy AT-845 in adults with late-onset Pompe disease.
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Seagen’s Tukysa gains US FDA accelerated approval for second cancer indication

Jan. 20, 2023
By Karen Carey

The U.S. FDA granted accelerated approval to Seagen Inc. on Jan. 19 for Tukysa (tucatinib), extending the therapy’s reach beyond HER2-positive metastatic breast cancer, and clearing its way for RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer.


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Cidara brings rezafungin to an FDA adcom

Jan. 20, 2023
By Lee Landenberger
Next week, Cidara Therapeutics Inc. will make its case for rezafungin, an injectable treatment for candidemia and invasive candidiasis in adults, before the U.S. FDA’s Antimicrobial Drugs Advisory Committee. When it convenes Jan. 24, the adcom will vote either yes or no if it believes the overall benefit-risk assessment is favorable for the use of rezafungin for treating candidemia/invasive candidiasis in adults with limited or no alternative treatment options.
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FDA icons and doctor

Apocalypse later? Lilly CRL for donanemab in AD no bombshell, phase III data key

Jan. 20, 2023
By Randy Osborne
Eli Lilly and Co.’s complete response letter (CRL) from the U.S. FDA relating to accelerated approval of Alzheimer’s disease (AD) candidate donanemab set off a round of speculation regarding not only what the move might mean for the pharma giant but also for others in the embattled therapeutic space and beyond. The answer, if you believe analysts: not much.
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Regulatory actions for Jan. 20, 2023

Jan. 20, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Conventus Flower.
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Regulatory actions for Jan. 20, 2023

Jan. 20, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Celltrion, Evaxion, Intercept, Linnaeus, Mitsubishi, Nrx, Panbela, Viracta.
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FDA seeks feedback on non-NEST user fee monies for real-world evidence

Jan. 19, 2023
By Mark McCarty
The fifth medical device user fee agreement (MDUFA V) is a generous bump in monies for the U.S. FDA, some of which will go toward advancing the use of real-world evidence (RWE) in the agency’s regulatory decisions. The FDA just opened a docket for comment on how those monies might be doled out to entities other than the Medical Device Innovation Consortium (MDIC), an expansion that might nudge the regulatory science along a little more quickly and thus enhance the use of RWE for premarket submissions.
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