• Regulatory NewsRegulatory News

    TGA and Health Canada Share Experiences With Mutually Relying on Other Inspectors’ Findings

    • 22 May 2019
    Almost a year after the Pharmaceutical Inspection Co-operation Scheme (PIC/S) adopted a new guideline allowing regulators to rely on their peers’ good manufacturing practice (GMP) inspections, Health Canada and Australia’s Therapeutic Goods Administration (TGA) shared some early results.
  • Regulatory NewsRegulatory News

    House Committee Proposes 6% Increase in FDA Funding for FY 2020

    • 22 May 2019
    The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the US Food and Drug Administration (FDA), calling for a $184 million increase in discretionary funding over 2019’s enacted level.
     
  • Regulatory NewsRegulatory News

    FDA Solicits PreCert Software Developer Volunteers

    • 22 May 2019
    The US Food and Drug Administration (FDA) on Wednesday put out a call for digital health software developers to participate in the agency’s software precertification (Pre-Cert) program as part of its 2019 Test Plan.
  • Regulatory NewsRegulatory News

    Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

    • 22 May 2019
    The US Food and Drug Administration (FDA) on Wednesday published its plans for the latest proposed and final rulemakings for drug and medical device companies, with new proposals related to the Right to Try law, investigational new drug (IND) application reporting requirements and amendments to patent term restoration.
     
  • Feature ArticlesFeature Articles

    Global Medical Device Cybersecurity Compliance Requirements

    • 22 May 2019
    This article discusses compliance requirements to maintain global medical device cybersecurity.
  • Regulatory NewsRegulatory News

    TÜV SÜD Becomes Second NB to be Designated Under EU MDR

    • 22 May 2019
    Germany-based TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the second notified body (NB) to be designated and notified under the new EU Medical Devices Regulation (MDR).
     
  • Regulatory NewsRegulatory News

    Drug Regulators Look to Harmonize How They Tackle Innovation

    • 21 May 2019
    The International Coalition of Medicines Regulatory Authorities (ICMRA) recently released a report on how various regulators worldwide are working together to better identify and address future regulatory challenges posed by new categories of therapeutics, like cell and gene therapies, and new tools for drug development, such as artificial intelligence (AI).
     
  • Regulatory NewsRegulatory News

    FDA Chief of Staff Calls OTC Monograph Reform a Top Priority

    • 21 May 2019
    In a speech at the Consumer Healthcare Products Association’s Regulatory, Scientific and Quality Conference on Tuesday, US Food and Drug Administration (FDA) Chief of Staff Lauren Silvis said the agency is committed to boosting access to safe and effective nonprescription drugs.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe

Most Viewed Articles

  • Almost Half of All New Drug Approvals in 2018 Relied on One Clinical Trial

    • 14 May 2019
    Back in the 1970s and 1980s, the US Food and Drug Administration (FDA) made clear that at least two adequate and well-controlled studies were necessary to establish a new drug’s effectiveness, except in only the rarest of circumstances.
     
  • ICH Updates: What’s Coming in 2019 and Beyond

    • 29 April 2019
    US Food and Drug Administration (FDA) officials on Monday morning held a meeting to offer a rundown of what needs to be done and what to expect from more than a dozen different International Council for Harmonisation (ICH) guidelines.
     
  • FDA Raises Concerns With Novartis in Clinical Inspection

    • 06 May 2019
    As part of Novartis’ new drug application for its recently approved multiple sclerosis drug Mayzent (siponimod), the US Food and Drug Administration (FDA) questioned the drugmaker’s data practices during a clinical inspection.
  • Woodcock Details Upcoming Changes to NDA and BLA Review Process

    • 02 May 2019
    A modernization of the way the US Food and Drug Administration (FDA) reviews new drug applications (NDAs) and biologic license applications (BLAs) will be instituted over the next two years, Center for Drug Evaluation and Research (CDER) Director Janet Woodcock told attendees of the Food and Drug Law Institute’s annual conference on Thursday.
Regulatory Focus ArticlesRSS 2.0