• Sign In
  • Sign Out
  • My Account
Subscribe
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
  • Special reports
Clarivate
  • Data Snapshots
  • BioWorld
  • BioWorld MedTech
  • Infographics: Dynamic digital data analysis
  • Special reports
  • Infographics: Dynamic digital data analysis
  • Trump administration impacts
  • Biopharma M&A scorecard
  • BioWorld 2024 review
  • BioWorld MedTech 2024 review
  • BioWorld Science 2024 review
  • Women's health
  • China's GLP-1 landscape
  • PFA re-energizes afib market
  • China CAR T
  • Alzheimer's disease
  • Israel
  • Rise of obesity
  • Radiopharmaceuticals
  • Biosimilars
  • Aging
  • IVDs on the rise
  • Coronavirus
  • Artificial intelligence

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Biopharma slams judge’s mifepristone ruling

April 10, 2023
By Mari Serebrov
Hundreds of executives from biopharma companies are signing onto an April 10 letter decrying a U.S. district judge’s decision last week to stay the FDA approval of mifepristone, which is used in more than half of all abortions in the U.S.
Read More

Regulatory actions for April 10, 2023

April 10, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Brim, CNS, Enanta, Everest, Merck.
Read More
Freestyle Libre 3 sensor with smartphone app

Abbott warns against use of non-proprietary charging cables for Freestyle Libre

April 6, 2023
By Mark McCarty
Batteries used in medical devices don’t always perform as expected, but Abbott Laboratories has issued an advisory to users of its Freestyle glucose monitoring systems in connection with overheating of the batteries used in the device’s readers, a problem the company said is not related to the batteries themselves. Abbott Park, Ill.-based Abbott has received reports of battery swelling and overheating in the reader unit, but advised users that use of non-Abbott charging cables seems to drive the risk of such episodes, urging users to stick with the USB charging cables that came with the readers.
Read More

FDA retains ‘handling’ in device animal studies final guidance

April 6, 2023
By Mark McCarty
The U.S. FDA has wrapped up an October 2015 draft guidance for animal studies for medical devices, which prompted some lengthy responses from stakeholders concerned about some unique terms, such as device “handling.” Despite industrial opposition to the inclusion of that term, the final guidance retains the term handling and defines it in part as the manner in which the device “responds to the demands of the operator,” a term that may or may not be encompassed by the FDA’s overarching policy for human factors engineering.
Read More

Regulatory actions for April 6, 2023

April 6, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Edap Tms, Icentia, Restor3d.
Read More

In rare move, US FDA withdraws approval for Makena

April 6, 2023
By Mari Serebrov
The long-running Makena saga came to a close April 6 with the U.S. FDA announcing its decision to immediately withdraw approval of the drug and its generics – the only drugs indicated in the U.S. to reduce the risk of preterm birth.
Read More

Regulatory actions for April 6, 2023

April 6, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, AB Science, Accord, Advantage, Direct, Edesa, Inflarx, Mirum, Perfuse, Soligenix, Verismo.
Read More

Maker of femoral resurfacing cup hit with warning for failure to file new 510(k)

April 5, 2023
By Mark McCarty
The U.S. FDA has issued a guidance on when to file a new 510(k) for a class II device that has undergone significant modification, but that doesn’t mean everyone in the device business is paying attention. The FDA hit Synovo Production Inc., of Fullerton, Calif., for a number of violations of the Quality System Regulation (QSR), but also alleged that the manufacturer/specification developer made a number of modifications to its femoral resurfacing cup for hip implants without a new regulatory filing, leading the agency to direct the company to immediately cease production of the device.
Read More
3D illustration and light micrograph of lung cancer.

US National Cancer Plan a potential windfall for diagnostics, diagnostic imaging

April 5, 2023
By Mark McCarty
The Biden administration has released the National Cancer Plan, a framework that expands and builds on the Cancer Moonshot program which came into being in 2016. The National Cancer Plan includes a strategies section that calls for development of new methods for detecting cancer and new imaging technologies for early cancer detection, just two provisions that would seem to portend good times ahead for companies that manufacture these products.
Read More

Regulatory actions for April 5, 2023

April 5, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abyrx, Synapse Biomedical, Zap Surgical.
Read More
Previous 1 2 … 301 302 303 304 305 306 307 308 309 … 1258 1259 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for June 6, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for June 6, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for June 3, 2025
  • Biotech deal illustration

    City hits the town with $1B-plus deal with Biogen

    BioWorld
    A development deal with Biogen Inc. could eventually bring City Therapeutics Inc. about $1 billion in milestone payments. It’s a step in the direction the company...
  • Cancer cell in the cross-hairs

    Pan-cancer proteome atlas reveals new biomarkers and targets

    BioWorld Science
    An international group of scientists has completed the first draft of The Pan-Cancer Proteome Atlas (TPCPA). The project is based on mass spectrometry of 22...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe