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Home » Topics » Regulatory

Regulatory
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Vercise Neural Navigator with Stimview XT software on tablet

FDA approval stimulates Boston Scientific’s Neural Navigator

April 12, 2022
By Annette Boyle
Boston Scientific Corp.’s image-guided programming software, Vercise Neural Navigator with Stimview XT, got the green light from the FDA for use with the company’s deep brain stimulation (DBS) portfolio in patients with essential tremor or Parkinson’s disease. The software, developed in a collaboration with Brainlab AG, provides more sophisticated image-guided programming tools for personalization of the stimulation therapy, halving the time needed for adjustments and increasing precision.
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Illustration of cell dividing

Newstem files for haploid human embryonic stem cell-based diagnostic

April 12, 2022
By Catherine Longworth
Newstem Ltd. filed a presubmission to the U.S. FDA for a de novo request and an in vitro diagnostic device with the EMA for its Newstem software diagnostic device (NSDD). The bioinformatics-based platform is a personalized diagnostic to inform oncologists about the presence of mutations in tumors and predict a patients’ resistance to chemotherapy treatments. The technology utilizes specialized stem cells (haploid cells) that carry just one set of chromosomes.
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Third-party reviews of 510(k) applications trending nearly flat since 2018

April 12, 2022
By Mark McCarty
The FDA program for third-party review of 510(k) applications was designed to take some of the load off the agency’s review staff and thus allow the agency to focus on more complex filings, but recent data suggest that the program has had only a modest effect on the FDA’s workload. The number of third-party reviews for the current and two previous fiscal years only modestly exceed the numbers from fiscal years 2018 and 2019, a conspicuous trend given the distractions at the FDA’s device arising from its work to manage the COVID-19 pandemic.
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Laptop displaying FDA logo

FDA strikes aggressive tone in new draft guidance for premarket cybersecurity

April 12, 2022
By Mark McCarty
For the second time in four years, the FDA has issued a draft guidance for cybersecurity in premarket applications, just one of several actions undertaken recently by the U.S. federal government in connection with cybersecurity.
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Regulatory actions for April 12, 2022

April 12, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocardia, Boston Scientific, Novacyt, Transit Scientific.
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Woman applying skin cream to elbow

Duo promotions for Duobrii not acceptable, U.S. FDA says again

April 12, 2022
By Mari Serebrov
The twos have it as the U.S. FDA’s Office of Prescription Drug Promotion, in its second untitled letter of the year, took Bausch Health Cos. Inc. to task over two promotions of its plaque psoriasis lotion, Duobrii (halobetasol propionate and tazarotene).
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Pill bottles, blister packs in a package

Northern Ireland drug supply secured with latest Brexit solution

April 12, 2022
By Mari Serebrov
Making it a done deal, the European Council adopted proposals April 12 to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K.
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Antibiotic-capsules-in-blister-packs.png

Pfizer, Shionogi antibiotics in first guidance for UK fixed-fee plan

April 12, 2022
By Nuala Moran
The U.K. plan to fix the market failure in antibiotics has taken a significant step forward with the publication of guidance estimating the value of two drugs to the National Health Service.
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Map of Australia, vaccine vial and syringe

Australia to allow imports of overseas medicines to mitigate drug shortages

April 12, 2022
By Tamra Sami
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods.
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China issues new audit rules and weighs giving U.S. regulators full access to audits

April 12, 2022
By Doris Yu
The China Securities Regulatory Commission has issued draft rules to permit U.S. auditors to examine U.S.-listed Chinese companies on April 2, 2022, following a provisional list by the U.S. SEC. The draft rules specified the requirement for the overseas-listed companies and relevant securities service providers to disclose confidential materials in overseas offerings and listing.
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