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    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 Launches Probe into Drug-containing Balloons, Stents

    • 18 January 2019
    Paclitaxel-coated balloons and paclitaxel-eluting stents prompted a US Food and Drug Administration (FDA) letter to health care providers after a 2018 meta-analysis suggested an increased mortality rate in patients that received peripheral arterial disease (PAD) treatment with either of the device types.
     
  • Regulatory NewsRegulatory News

    FDA Approves 17th Biosimilar, Third for Herceptin

    • 18 January 2019
    The US Food and Drug Administration (FDA) on Friday approved Merck and Samsung Bioepis’ Ontruzant (trastuzumab-dttb), the third biosimilar approved in the US to Roche’s Herceptin (trastuzumab).
     
  • Regulatory NewsRegulatory News

    Industry Calls for Metrics on CDRH’s Breakthrough Device Program

    • 18 January 2019
    A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority review program run by FDA’s Center for Devices and Radiological Health (CDRH).

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Recon
Recon: Chinese Scientist May Face Criminal Charges After Editing Babies' Genes
21 January 2019
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Chinese Scientist May Face Criminal Charges After Editing Babies' Genes Recon: FDA Panel Split on Sanofi-Lexicon Diabetes Drug; Lilly's Latruvo Fails Confirmatory Study Recon: NICE Recommends Lilly's Verzenios for Advanced Breast Cancer; J&J to Use Apple Watch for Heart Study
Regulatory News
More FDA Furloughs Expected, Gottlieb Warns
21 January 2019
As the government shutdown enters its second month, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and fellow leaders at the agency will be tasked with difficult decisions on who to furlough.
 
More FDA Furloughs Expected, Gottlieb Warns NESTcc Unveils 2019 Operational Plan to Serve as ‘Front Door to Conduct RWE Studies’ FDA Launches Probe into Drug-containing Balloons, Stents
Feature Articles
The Enforcement of Risk Evaluation and Mitigation Strategy (REMS)
21 January 2019
This article describes the evolution of Risk Evaluation and Mitigation Strategy (REMS) from a safety program to an enforcement tool
The Enforcement of Risk Evaluation and Mitigation Strategy (REMS) The Changing Landscape of Drug Promotion in a Digital World and What it Means for Regulatory Reviewers Cybersecurity, Supply Chain Security, Good Distribution Practices and FDA’s Drug Registration Process
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
29 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 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 2019 Board of Directors Begins Term; Don Boyer Takes Helm as Chair
18 January 2019
RAPS welcomed its 2019 board of directors, which officially began its term on 1 January. Don Boyer, a former top Health Canada official who is now a private regulatory consultant, takes over as chairman.
RAPS 2019 Board of Directors Begins Term; Don Boyer Takes Helm as Chair RAPS Welcomes Utah Chapter Making the Switch to Advertising and Promotion: My First 90 Days
Sponsored Content
Preparing for successful meetings with the FDA
02 January 2019
Meeting with the FDA offers sponsors an opportunity to seek out critical feedback, provide background on their product and demonstrate the effectiveness of their studies. The right experience, preparation and planning is necessary to make the most of these meetings and help ensure a level of confidence with the FDA. Read on to learn about the three types of FDA meetings and gain insights for optimizing these opportunities.
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