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Home » Topics » Regulatory

Regulatory
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US FDA to consider lower efficacy for kids’ vaccine

May 9, 2022
By Mari Serebrov
The U.S. FDA’s efficacy bar for COVID-19 vaccines for the youngest children may be lower than the 50% required for the adult vaccines, according to Peter Marks, director of the agency’s Center for Biologics Evaluation and Research.<
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Hand holding FDA blocks

US FDA issues draft CMC guidance

May 9, 2022
In a draft guidance released May 9, the U.S. FDA described the benefit-risk principles it uses when conducting quality-related assessments of chemistry, manufacturing and controls (CMC) information submitted as part of a new drug application, biologics license application or supplement.
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Ignoring the courts, US HHS presses forward on 340B enforcement

May 9, 2022
By Mari Serebrov
Even though at least two different U.S. district courts have ruled that the 340B enforcement letters the Department of Health and Human Services’ (HHS) Health Resources and Services Administration has sent to biopharma companies violate the Administrative Procedures Act, the agency continues to send the letters, along with threats of civil money penalties, to companies that place restrictions on the 340B discounts to contract pharmacies.
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Regulatory actions for May 9, 2022

May 9, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cvrx, Lucira Health, Philips.
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Regulatory actions for May 9, 2022

May 9, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Johnson & Johnson, Myovant, Pfizer.
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Digital spine concept art

Nanox unit wins FDA clearance for spine analysis device

May 6, 2022
By Gina Lee
Nano-x Imaging Ltd.’s (Nanox) subsidiary Nanox.AI has received the FDA’s 510(k) clearance for Healthost, an artificial intelligence (AI) software device providing qualitative and quantitative analysis of the spine from CT scans.
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Syringe with Johnson & Johnson logo

Better than nothing: FDA limits use of J&J COVID-19 vaccine

May 6, 2022
By Michael Fitzhugh
A risk of rare but potentially life-threatening blood clots in combination with low platelet levels after a jab of Johnson & Johnson's Janssen COVID-19 vaccine has convinced the U.S. FDA to limit its use. The vaccine is now authorized in the U.S. only for adults who wouldn't otherwise be vaccinated and those who can't or shouldn't, for medical reasons, get another approved vaccine. Through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases of the condition, called thrombosis with thrombocytopenia syndrome – a rate of 3.23 cases per million doses of vaccine administered.
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Regulatory actions for May 6, 2022

May 6, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bio Products, Daiichi, Incyte, Jiangsu Recbio, Kempharm, Moleculin, Newsoara, Palisade, Vistagen, Xortx.


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Lumipulse-G

FDA grants Fujirebio first marketing authorization for in vitro diagnostic for Alzheimer’s

May 5, 2022
By Annette Boyle
Mark it as a day to remember. The U.S. FDA has awarded de novo marketing authorization for the first in vitro diagnostic (IVD) test for Alzheimer’s disease (AD), enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
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EU flag, map, charts
Medtech Forum

Medtech leaders call for innovation friendly environment in Europe

May 5, 2022
By Catherine Longworth
When it comes to innovation, Europe has a thing or two it can learn from the U.S. according to European leaders. Speaking at the Medtech Forum meeting in Barcelona, Medtech Europe CEO Serge Bernasconi said Europe’s focus on safety issues is stifling innovation across the continent.
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