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Home » Topics » Regulatory

Regulatory
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OIG says FDA’s stumbles in COVID testing EUAs highlights need for national strategy

Sep. 21, 2022
By Mark McCarty
The U.S. response to the emergence of the COVID-19 pandemic may by now be the stuff of public health policy lore, with both the FDA and the CDC contributing to the chaos in the first months of the pandemic. The Office of Inspector General has issued an analysis of the situation, and while OIG revisited some of the known miscues, the report also made the case that a national strategy for pandemic response will be needed if federal government efforts in the future are to be less a hazard to the lives of American citizens than those seen in the first half of 2020.
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Medical illustration of human feet, nervous system, veins, arteries

Lepu Medical wins China’s first approval for peripheral cutting balloon to treat PAD

Sep. 20, 2022
By Doris Yu
Lepu Medical Technology (Beijing) Co. Ltd. received marketing approval from China’s NMPA for its peripheral cutting balloon to treat peripheral arterial disease.
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Infant examination

Astrazeneca-Sanofi RSV prevention drug Beyfortus gets nod from EU regulators

Sep. 20, 2022
By Richard Staines
An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023.
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Xray showing lung cancer on tablet

Spectrum, Oncopeptides fall on US FDA briefing docs ahead of ODAC meet

Sep. 20, 2022
By Mari Serebrov
The fate of three cancer drugs, and possibly the future financial health of their sponsors, could be on the line Sept. 22 and 23 as the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) takes a hard look at the safety-efficacy data for Spectrum Pharmaceuticals Inc.’s Pozenveo, Oncopeptides AB’s Pepaxto and Secura Bio Inc.’s Copiktra. First up in the triple-header is Pozenveo (poziotinib), which is seeking accelerated approval as a second-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer harboring HER2 exon 20 insertion mutations confirmed by an FDA-approved test.
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Regulatory actions for Sept. 20, 2022

Sep. 20, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Medtronic, Oswaldo Cruz Foundation, Predicine, Stryker, Zimmer Biomet.
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Regulatory actions for Sept. 20, 2022

Sep. 20, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Biontech, Bridgebio, Sentynl, Cellevolve, Decibel, Junshi, Mediwound, Pfizer, Verismo, Veru, Xpira.
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NIH officially launces Bridge2AI for artificial intelligence in biomedical research

Sep. 19, 2022
By Mark McCarty
The U.S. NIH is not generally regarded as a wellspring of concepts and policies in the world of artificial intelligence (AI), but that perception may change soon thanks to the agency’s Bridge2AI program. The agency announced recently that it will drop $130 million into this program over four years in an effort to develop standards for data used in AI research, a key development for device makers seeking to sell products that use these complex algorithms.
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Novum Iq

Baxter rings up FDA clearance for syringe Infusion pump and dosage safety software

Sep. 19, 2022
By David Godkin

Baxter International Inc. has scored FDA clearance for an infusion pump used to deliver small amounts of fluid at low rates, often in pediatric, neonatal and anesthesia care settings. The Novum Iq syringe infusion pump also features Dose Iq Safety Software, a web-based, customizable drug library that incorporates titration technology to reduce dosage errors during patient treatment.


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Novartis to FDA: No skinny labels for Entresto

Sep. 19, 2022
By Mari Serebrov
Claiming it would be impossible to carve out a so-called skinny label that would comply with generic drug “same labeling” rules, Novartis AG is petitioning the U.S. FDA, for the second time, not to approve generic versions of its blockbuster heart drug, Entresto (sacubitril + valsartan), that attempt to carve around a cardiovascular indication that has exclusivity until Feb. 16, 2024.
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EMA icons

EMA calls for biosimilar interchangeability across the EU

Sep. 19, 2022
By Mari Serebrov
In an effort to get drug regulators in the various EU member states on the same page, the EMA issued a Sept. 19 statement confirming that all biosimilars approved in the EU are interchangeable with other approved biosimilars referencing the same biologic, as well as the reference biologic itself.
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