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  • Feature ArticlesFeature Articles

    Visualizing Data

    • 12 December 2018
    This article discusses the history of making data visual and suggest ways to keep viewers of visual data engaged. 
  • Regulatory NewsRegulatory News

    Data Integrity Q&A: FDA Finalizes Guidance

    • 12 December 2018
    The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good manufacturing practice (CGMP) for drugs and biologics.
  • Regulatory NewsRegulatory News

    FDA Tweaks Final Guidance for PMAs and Device BLAs

    • 12 December 2018
    The US Food and Drug Administration (FDA) made minor revisions to a 2017 final guidance on Wednesday on user fees and refunds for premarket approval applications and device biologics license applications.
     
  • Regulatory NewsRegulatory News

    CBO Offers Positive Score for Senate Bill to Reform OTC Drug Regulations

    • 12 December 2018
    The Congressional Budget Office (CBO) this week said that a Senate bill that would create a new user fee program for over-the-counter (OTC) drugs would not increase the budget deficit.
     
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    Feature ArticlesFeature Articles

    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

    FDA Warns China’s Zhejiang Huahai Over Failures to Detect Impurities in Valsartan API Batches

    • 11 December 2018
    China-based Zhejiang Huahai Pharmaceuticals drew a US Food and Drug Administration (FDA) warning letter over failures to conduct investigations into impurities classified as probable human carcinogens.
     
  • Regulatory NewsRegulatory News

    House Floats Five Year Extension of Medical Device Tax

    • 11 December 2018
    The widely unpopular medical device excise tax would be delayed for another five years under a tax relief package introduced by the US House Ways and Means Committee on Monday.
     
  • Feature ArticlesFeature Articles

    Safety First

    • 11 December 2018
    This article reviews the development of global Good Distribution Practices (GDPs) against the background of an increasingly complex pharmaceutical supply chain, five years after the initial implementation of the extended EU GDP Guideline.
  • Regulatory NewsRegulatory News

    FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

    • 11 December 2018
    The US Food and Drug Administration (FDA) on Tuesday released two new draft Q&A guidance documents on biosimilar development and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as well as two final guidance documents on the same topics and one proposed rule amending the definition of a biological product.
     

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Recon
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Regulatory News
Data Integrity Q&A: FDA Finalizes Guidance
12 December 2018
The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good manufacturing practice (CGMP) for drugs and biologics.
FDA Tweaks Final Guidance for PMAs and Device BLAs CBO Offers Positive Score for Senate Bill to Reform OTC Drug Regulations TGA Clarifies SaMD Policies, Signals Changes to Classification Regulations
Feature Articles
Visualizing Data
12 December 2018
This article discusses the history of making data visual and suggest ways to keep viewers of visual data engaged. 
Safety First Separate Drug Approval in Children is not Based on Science Performing a GMP Audit
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
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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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