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    21st Century Cures Act and Acceleration of Device Approval

    • 17 October 2018
    This article discusses two critical provisions of the law meant to accelerate FDA approval of medical devices. It explains the benefits of the provisions, which have been criticized by consumer advocates in the past.
  • Regulatory NewsRegulatory News

    Majority of Open PMRs and PMCs Progressing on Schedule, FDA Report Shows

    • 16 November 2018
    The majority of the open postmarket requirements (PMRs) and commitments (PMCs) in the US Food and Drug Administration’s (FDA) database continues to progress on schedule, according to data in the latest report released Friday.
     
  • Regulatory NewsRegulatory News

    EMA Recommends First All-Oral Treatment for Sleeping Sickness

    • 16 November 2018
    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it has adopted a positive scientific opinion of Fexinidazole Winthrop (fexinidazole), the first oral-only medicine for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness.
     
  • Regulatory NewsRegulatory News

    Draft Brexit Agreement Moves Forward on Shaky Ground

    • 15 November 2018
    EU and UK negotiators on Wednesday advanced a draft agreement setting terms for the UK’s withdrawal from the EU in March 2019 and the two parties’ relationship during a 21-month transition period.
  • Regulatory NewsRegulatory News

    PMA Denials: Why so Few?

    • 15 November 2018
    In the pharmaceutical industry, complete response letters, or rejections, are a common occurrence. And though they aren’t frequently explained in detail publicly, the public is still usually notified that the company has received such a letter. But in the world of medical devices, failing to win approval for a high-risk device is a much more closely held secret, and companies can withdraw their applications rather than be denied approval.
     
  • Regulatory NewsRegulatory News

    Novartis Calls for FDA Enforcement Against Biosimilar Misinformation

    • 15 November 2018
    Building off a Pfizer citizen petition on biosimilar misinformation, Novartis is calling on FDA to set the record straight on what information can be disseminated.
  • Regulatory NewsRegulatory News

    Water Quality for Pharmaceutical Use: EMA Opens Consultation

    • 15 November 2018
    With the aim of replacing guidance from 2002 on quality of water for pharmaceutical use, the European Medicines Agency (EMA) is offering new draft guidance for industry on the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use.
  • Feature ArticlesFeature Articles

    LDT Regulation: Past, Present and Future

    • 15 November 2018
    This article summarizes the regulatory history of Laboratory Developed Tests (LDTs) and describes where we are now and where we may be heading.

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  • Insights on Upcoming Revisions to ISO 13485

    • 22 October 2018
    Following the new outcome meeting statement posted Monday by the management committee of the International Medical Device Regulators Forum (IMDRF), Focus obtained insights into upcoming revisions to the global standard for quality management systems (QMS), ISO 13485.
     

  • Amneal Wins First Priority Review ANDA Approval

    • 31 October 2018
    Amneal’s abbreviated new drug application (ANDA) for Carmustine for injection was the first ANDA to win a priority review – a new designation for generic drugs thanks to the FDA Reauthorization Act of 2017 (FDARA).
     

  • FDA Proposes Changes to Informed Consent Rules

    • 13 November 2018
    The US Food and Drug Administration (FDA) on Tuesday proposed changes that would allow institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for certain clinical trials involving minimal risk to participants.

  • FDA Flags Violations at Medical Device Firms in Sweden, Canada, Spain, UK

    • 30 October 2018
    Device firms in Sweden, Canada, Spain and the UK separately drew four US Food and Drug Administration (FDA) warning letters over good manufacturing practice (GMP) violations.
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Recon
Recon: FDA Expands Use of Seattle Genetics’ Adcetris Under Real-Time Review Pilot
16 November 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: United Therapeutics Licenses Arena’s Ph. III PAH Drug for $800M Recon: UK Supreme Court Rules Against Pfizer in Lyrica Patent Case Recon: Sobi Buys US Rights to AstraZeneca’s Infant Lung Infection Drug Synagis for $1.5B
Regulatory News
AdvaMed and AAMI Weigh FDA Draft Guidance on Voluntary Consensus Standards
16 November 2018
Medical device industry group AdvaMed and the Association for the Advancement of Medical Instrumentation (AAMI) are seeking additional information from the US Food and Drug Administration (FDA) on draft guidance related to the recognition and withdrawal of voluntary consensus standards.
 
Majority of Open PMRs and PMCs Progressing on Schedule, FDA Report Shows EMA Recommends First All-Oral Treatment for Sleeping Sickness Draft Brexit Agreement Moves Forward on Shaky Ground
Feature Articles
LDT Regulation: Past, Present and Future
15 November 2018
This article summarizes the regulatory history of Laboratory Developed Tests (LDTs) and describes where we are now and where we may be heading.
LDT Regulation: Past, Present and Future A Comparative Study of US and EU Medical Device Regulations Theoretical Perspective of Technology for Regulatory Science: Part 2
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
01 November 2018
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 Biosimilars Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022 Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA
About Regulatory Focus

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.

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