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    Feature ArticlesFeature Articles

    Transforming Regulatory Operations

    • 17 July 2019
    This article describes one global pharmaceutical company’s efforts to improve efficiencies, maintain compliance with new standards and gain greater internal alignment.
  • Regulatory NewsRegulatory News

    FDA Offers Technical Specifications for Submitting NGS Data on Antivirals

    • 18 July 2019
    The US Food and Drug Administration (FDA) on Thursday published a technical specifications document to help sponsors submit next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drugs.
  • Regulatory NewsRegulatory News

    FDA to Study Physicians’ Interpretations of Drug Information

    • 18 July 2019
    The US Food and Drug Administration (FDA) on Thursday said its Office of Prescription Drug Promotion (OPDP) will conduct a study to determine how factors such as information source, graphical presentations and time can influence physicians’ interpretation of information about prescription drugs presented in scientific journals versus promotional materials.
  • Regulatory NewsRegulatory News

    Patient Registries May Prove Valuable in Regulatory Decisions, EMA Study Finds

    • 18 July 2019
    Although patient registries can be heterogenous in their quality and design, a new study in Drug Safety co-authored by a European Medicines Agency (EMA) official explains how patient registries could provide valuable data for regulatory decisions.
  • Regulatory NewsRegulatory News

    Office of Generic Drugs Explains Research Conducted in First Year of GDUFA II

    • 18 July 2019
    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Thursday released a report on the two dozen research grants awarded related to complex generics in 2018, as well as the research done in seven other areas, including data analytics and combination products. 

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Most Viewed Articles

  • US and EU Fully Implement Mutual Agreement on GMP Inspections

    • 12 July 2019
    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on Friday said they have now fully implemented a plan that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities.
     

  • EC Offers Two New Guidance Documents on MDR/IVDR

    • 01 July 2019
    The European Commission (EC) on Monday released one new guidance on persons responsible for regulatory compliance under the Medical Device Regulation (MDR) and the in vitro Diagnostic Device Regulation (IVDR), and another guidance on the implant card required by MDR.

  • Manufacturing Concerns Lead FDA to Pull 31 Apotex ANDAs

    • 09 July 2019
    The US Food and Drug Administration (FDA) on Tuesday said it is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex after manufacturing deficiencies were found at two of the company’s plants.
     

  • UL UK to Sunset Operations Under EU’s Medical Device Directive

    • 08 July 2019
    UL UK says it will no longer operate as a notified body (NB) under the EU’s medical device directive (MDD) and limit its work under the in vitro diagnostic directive (IVDD).
     
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Recon
Recon: Amgen and Allergan Launch Avastin and Herceptin Biosimilars
19 July 2019
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Amgen and Allergan Launch Avastin and Herceptin Biosimilars Recon: Novartis Sets Aside $700M to Settle US Bribery Suit Recon: FDA Approves Merck’s Antibiotic Recarbrio to Treat Complicated Infections
Regulatory News
Medical Device Premarket Cybersecurity: TGA Finalizes Guidance
19 July 2019
The premarket requirements on medical device cybersecurity from Australia’s Therapeutic Goods Administration (TGA) came into effect on Thursday, with new details that further underscore the agency’s push for the total product lifecycle (TPLC) approach and international harmonization.
 
Medical Device Premarket Cybersecurity: TGA Finalizes Guidance FDA Discusses RWD, RWE With Industry, Academia EU Ombudsman Concludes Inquiry on EMA Interactions With Medicine Developers
Feature Articles
India’s New Drugs and Clinical Trials Rules: An Industry Perspective
19 July 2019
This article highlights the recently published, revised regulatory pathway in India and focuses on the regulatory changes and their impact on industry and on clinical trials.
India’s New Drugs and Clinical Trials Rules: An Industry Perspective Transforming Regulatory Operations Comparison of Data Requirements for the Approval of a Biosimilar Versus the Reference Medicine
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
24 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
About Regulatory Focus

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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
RAPS Publishes Updated Fundamentals of US Regulatory Affairs Book
17 July 2019
RAPS has published the updated, 11th edition of Fundamentals of US Regulatory Affairs, the most extensive regulatory affairs textbook available, covering US regulations for pharmaceuticals, medical devices, biologics and related healthcare products.
RAPS Publishes Updated Fundamentals of US Regulatory Affairs Book Canadian Regulator and Regulatory Experts to Speak at 2019 Convergence 7 Things Attendees Love About the Regulatory Convergence
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