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Home » Topics » Regulatory

Regulatory
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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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US FDA provides draft guidance on mpox drugs

Jan. 19, 2023
By Mari Serebrov
Just as the U.S. mpox public health emergency declaration is about to end, the FDA is releasing a draft guidance on developing drugs and biologics to treat infections caused by the virus.
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Map of Europe

EFPIA: Borders shouldn’t be barriers to EU clinical trials

Jan. 19, 2023
By Mari Serebrov
In the absence of a European framework, industry is stepping up with an initiative to help EU patients cross borders to participate in clinical trials.
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US GAO: Improved oversight needed for high-risk research

Jan. 19, 2023
By Mari Serebrov
The U.S. Department of Health and Human Services received low marks on its latest Government Accountability Office (GAO) report card for its oversight of high-risk research involving potential pandemic pathogens, but legislative fixes might be necessary to ensure that all the gaps are closed.
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Regulatory actions for Jan. 19, 2023

Jan. 19, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Selux.
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Regulatory actions for Jan. 19, 2023

Jan. 19, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations:  Abbisko, Atyr, Avidity, Briacell, Cyrano, Exegenesis, Hutchmed, Junshi, Krystal, Novavax, Orphagen, Paratek, Pharmather, Sanofi, Scisparc, Takeda.
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Resolute FDA churning out de novo announcements in effort to catch up

Jan. 18, 2023
By Mark McCarty
The new year always brings with it a series of New Year’s resolutions, and the U.S. FDA has apparently resolved to catch up on its backlog of de novo notifications. The earlier of the two de novo regulatory announcements is for a digital product by Minneapolis-based Nightware Inc., and its namesake kit for reduction of sleep disturbances, a regulation that arrives more than two years after the product was granted market access.
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Blood cells and bacteria

Cytovale gets FDA nod for 10-minute sepsis test

Jan. 18, 2023
By Annette Boyle

Cytovale Inc. received U.S. FDA 510(k) clearance for its Intellisep sepsis test, which can aid in the diagnosis of the often fatal condition within 10 minutes. Cytovale is one of several companies and collaborations that aim to sharply reduce the time to diagnosis and the mortality rate for sepsis by providing quicker, more informative test results and standardizing protocols.


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Document signing

US FTC proposes making noncompetes a thing of the past

Jan. 18, 2023
By Mari Serebrov
If the U.S. FTC has its way in banning all noncompete employment agreements, a lot of biopharma and med-tech companies are going to have to rethink how they protect sensitive information and business strategies.
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China approves world’s first tocilizumab biosimilar by Bio-Thera

Jan. 18, 2023
By Doris Yu
Bio-Thera Solutions Ltd. has obtained NMPA approval for BAT-1806 to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis and cytokine release syndrome. BAT-1806 is the world’s first tocilizumab biosimilar approved for marketing, according to Guangzhou, China-based Bio-Thera.
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