• 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
  • Index insights
  • 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
  • Coronavirus
  • More reports can be found here

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • 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
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
Home » Authors » Mark McCarty

Articles by Mark McCarty

U.S. at night from space with circuit board overlay

FDA staff can access management meeting notes in QMSR final rule

Jan. 31, 2024
By Mark McCarty
The U.S. FDA dropped the final rule for the Quality Management System Regulation (QMSR), the long-awaited blending of the agency’s own Quality System Regulation (QSR) and ISO 13485.
Read More
Toy bulldozer moving FDA letter blocks

FDA’s real-world evidence draft expands data requirements

Jan. 30, 2024
By Mark McCarty
The U.S. FDA’s latest draft guidance for the use of real-world evidence (RWE) is a substantially heftier document than the 2017 final guidance that will shortly become obsolete, and buried in all those extra pages are a few key details.
Read More
Laptop displaying FDA logo

FDA draft for third-party EUA reviews lacks timeline commitments

Jan. 30, 2024
By Mark McCarty
The U.S. FDA has redrafted an existing guidance for third-party reviews of 510(k) submissions to include submissions under the emergency use authorization (EUA) program, which generally speaking should be good news. The problem with the draft is that these third parties will have to interact frequently and substantively with the FDA in EUA reviews, and the lack of prescribed timelines in the FDA draft suggests that while the use of third parties may help the agency manage any future EUA workloads, the total turnaround time for these applications might not be significantly better than was seen during the COVID-19 pandemic.
Read More
Brain with stroke illustration

UK’s NICE easing into artificial intelligence for stroke

Jan. 26, 2024
By Mark McCarty
To date, developers of digital health technologies have had little luck with coverage and reimbursement, but the picture is slowly improving. The U.K.’s National Institute for Health and Care Excellence (NICE) has endorsed two artificial intelligence (AI) algorithms for diagnosis of stroke, although this is limited to an evidence generation framework that puts the sponsors on the hook for generating the data that will allow unlimited use in the U.K.’s trusts.
Read More
Digital brain and silhouette

FDA’s device center meets MDUFA hiring goals in fiscal 2023

Jan. 25, 2024
By Mark McCarty
The U.S. FDA’s device center has at times struggled to make the volume of hires under the reigning Medical Device User Fee Agreement (MDUFA), but that wasn’t a problem in fiscal year 2023.
Read More
Gavel and scales

Device maker convicted for forgery of FDA documents

Jan. 25, 2024
By Mark McCarty
The U.S. Department of Justice (DOJ) has announced a conviction obtained in federal court of an employee of a medical device manufacturer who was charged with forging documents that purported that his employer had obtained clearance for two medical devices. Peter Stoll III, who was employed by Aesculap Inc., of Center Valley, Pa., will serve 12 months in prison and a year of supervised release in one of the most egregious examples of fraudulent med tech behavior in recent memory.
Read More
U.S. Capitol building

New effort to reform patent eligibility in play in US Senate

Jan. 24, 2024
By Mark McCarty
The ongoing controversy over patent subject matter eligibility gained new momentum via a Jan. 23 U.S. Senate hearing, during which a bipartisan pair of senators once again pushed the argument that current jurisprudence for subject matter eligibility is hampering U.S. life science companies.
Read More
EU flags

European Commission provides another delay in IVDR compliance deadlines

Jan. 24, 2024
By Mark McCarty
The European Commission (EC) has proposed another delay in the compliance deadlines for the In Vitro Diagnostic Regulation (IVDR) that eases the existing timelines by roughly two and a half years. The news was welcomed by Medtech Europe, which nonetheless pressed the EC and others to patch up some of the issues that led to the new extensions in the first place.
Read More
Laptop displaying FDA logo

US FDA says reorganization a tough slog in tight budgetary environment

Jan. 23, 2024
By Mark McCarty
The U.S. FDA is undergoing a significant overhaul of operations which is designed in part to make the agency’s Office of Regulatory Affairs (ORA) more efficient and less obtrusive to product centers, such as the Center for Devices and Radiological Health.
Read More
Microscope with beakers and flasks

Advamed wary of government plan to privatize US helium depot

Jan. 23, 2024
By Mark McCarty
Legislation passed in the U.S. Congress in 2013 called upon the federal government to dispense with the Federal Helium Reserve by September 2021, a deadline that some stakeholders are grateful to see has passed without action.
Read More
Previous 1 2 … 50 51 52 53 54 55 56 57 58 … 561 562 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 25, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for July 25, 2025.
  • Brain and neural networks

    Proteomics finds surprise commonalities as well as differences in neurodegenerative diseases

    BioWorld
    The switch will be flicked today to make the world’s largest dementia-related proteomics dataset freely available to researchers, at the same time as members of...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for July 22, 2025
  • Pfizer describes new STAT6 inhibitors

    BioWorld Science
    Pfizer Inc. has identified signal transducer and activator of transcription 6 (STAT6) inhibitors reported to be useful for the treatment of Alzheimer’s disease,...
  • 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
    • Index insights
    • 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
    • Index insights
  • 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
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe