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  • 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.
     
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    Regulatory NewsRegulatory News

    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.
     
  • 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.

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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.
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Recon
Recon: Amgen to Buy Scandinavian Biotech Nuevolution for $167M
22 May 2019
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Amgen to Buy Scandinavian Biotech Nuevolution for $167M Recon: Merck to Buy Peloton for $1.1B to Boost Cancer Pipeline Recon: Canadian Fund Buys Keytruda Rights from UK's LifeArc for £1B
Regulatory 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.
TGA and Health Canada Share Experiences With Mutually Relying on Other Inspectors’ Findings House Committee Proposes 6% Increase in FDA Funding for FY 2020 FDA Solicits PreCert Software Developer Volunteers
Feature Articles
Global Medical Device Cybersecurity Compliance Requirements
22 May 2019
This article discusses compliance requirements to maintain global medical device cybersecurity.
Global Medical Device Cybersecurity Compliance Requirements Communication With the Chinese Center of Drug Evaluation (CDE) During Drug Development Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
08 May 2019
Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers Regulatory Explainer: Everything You Need to Know About Biosimilars Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022
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Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.

RAPS' Latest
MDR, IVDR and ‘Navigating the Grey’ Key Topics at RAPS Regulatory Conference Europe Opening
13 May 2019
The RAPS Regulatory Conference Europe 2019 kicked off in Brussels Monday with a lively discussion among expert panelists representing European health authorities, notified bodies, and industry groups as well as other regulatory professionals including RAPS members from around the world. 
MDR, IVDR and ‘Navigating the Grey’ Key Topics at RAPS Regulatory Conference Europe Opening Focus on: Bill Sietsema European and UK Health Authority Officials, Industry Leaders, Notified Body Reps, Other Experts to Speak at RAPS’ Europe Conference
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