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Home » Topics » Regulatory

Regulatory
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DNA illustration

DNA Electronics earns breakthrough device designation for Lidia-seq

April 9, 2020
By Nuala Moran
LONDON – DNA Electronics Ltd. (DNAe) won a U.S. FDA breakthrough device designation for its semiconductor-based DNA sequencing technology Lidia-seq and for the first assay based on the platform, which will detect bloodstream infections and antimicrobial resistance (AMR) genes at point of care.
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FDA posts OUS device warnings as U.S. company receives second warning in three years

April 9, 2020
By Mark McCarty
The FDA’s device center has resumed a more normal pace of warning letter issuance in recent months, and the latest batch posted to the warning letter website features warning letters to one device maker in Europe and three firms in Asia. One U.S. firm, Steiner Biotechnology LLC, of Henderson, Nev., also received a warning, however, which is the second the company has received since June 2017.
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Vapotherm’s Oxygen Assist Module wins FDA breakthrough device nod

April 9, 2020
By Meg Bryant
The U.S. FDA has granted breakthrough device designation to Vapotherm Inc. for its Oxygen Assist Module (OAM), for use with its Precision Flow assistive breathing systems. The new module is designed to aid clinicians in maintaining a targeted blood oxygen range in patients requiring oxygen therapy.
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4-9-Abbott-Triclip.png

Abbott scores win as Triclip secures CE mark

April 9, 2020
By Liz Hollis
Abbott Laboratories, of Abbott Park, Ill., reported that its Triclip transcatheter tricuspid valve repair system has received the CE mark. The device is a nonsurgical treatment for people with tricuspid regurgitation (TR), and, according to the company, it is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available. The Triclip is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood.
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Regulatory actions for April 9, 2020

April 9, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cipla, Diacarta, DNAe, Vapotherm, Silk Medical Aesthetics.
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Regulatory front for April 9, 2020

April 9, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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FDA Approved stamp

Pfizer's Array $11.2B buy yields more dividends with mCRC approval

April 9, 2020
By Michael Fitzhugh
A little more than eight months after Pfizer Inc.'s $11.2 billion acquisition of Array Biopharma Inc., a combination of Array-developed Braftovi (encorafenib) and cetuximab has won FDA approval for the second-line treatment of adults with BRAF V600E-mutant metastatic colorectal cancer (mCRC), becoming the first approved therapy specifically targeting that mutation.
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Language matters and so does time, FDA told in comments on biosimilar labeling

April 9, 2020
By Mari Serebrov
One simple four-letter word can make a world of difference in how quickly biosimilars and interchangeables bring full competition to the U.S. marketplace of biologics, a handful of companies and industry groups told the FDA in comments on a draft guidance concerning the labeling of follow-ons that are licensed for fewer indications than the reference biologic.
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European Union map and coronavirus

EMA activates COVID-19 pandemic task force to galvanize European regulatory response

April 9, 2020
By Cormac Sheridan
DUBLIN – The EMA has activated a COVID-19 task force to coordinate and accelerate the European regulatory response to the pandemic. The task force is intended to take a lead role in shaping the development, authorization and post-approval surveillance of drugs and vaccines for treating or preventing COVID-19 infection.
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Regulatory front for April 9, 2020

April 9, 2020
The latest global regulatory news, changes and updates affecting biopharma.
Read More
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