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    Global Opportunities and Requirements for Expedited Pathways

    • 16 May 2018
    This interview features insight from two leading industry executives, Bridget Heelan and Bhardwaj (Bob) Desai, on the complexities of expedited pathways in in the major markets of the US, EU and Japan and highlights expedited pathways with regard to significant benefit, clinical trials design and data, surrogate end points, orphan drugs, reimbursement and potential drawbacks to expedited pathways.
  • RAPS' LatestRAPS' Latest

    Focus on: Daniela Drago

    • 17 May 2018
    A conversation with Daniela Drago, head of the regulatory affairs program at The George Washington University and chair of the RAPS DC/Baltimore Chapter, as part of our new Regulatory Focus interview series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers from a variety of backgrounds.
  • Regulatory NewsRegulatory News

    US WorldMeds Wins FDA Nod for First Non-Opioid to Treat Opioid Withdrawal Symptoms

    • 16 May 2018
    Specialty drug company US WorldMeds’ Lucemyra (lofexidine hydrochloride) became the first non-opioid treatment for the management of opioid withdrawal symptoms among adults to receive US Food and Drug Administration (FDA) approval on Wednesday, according to an agency announcement.
     
  • Regulatory NewsRegulatory News

    FDA Hones In On Critical Issues With Recruitment, Inclusion of Women in Clinical Trials

    • 16 May 2018
    The US Food and Drug Administration (FDA) is looking to break down barriers hindering the availability of clinical trial data on women by focusing on two critical issues--enrollment and new products designed for treating conditions that are gender-unique.
     
  • Regulatory NewsRegulatory News

    FDA Faster Than Global Peers at Approving New Drugs

    • 16 May 2018
    A report from the Centre for Innovation in Regulatory Science (CIRS) released this month finds that the US Food and Drug Administration (FDA) has reclaimed its position as the fastest major regulator for approving new drugs and biologics.

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  • FDA Goes All Out With Digital Health Regulatory Paradigm Shift

    • 26 April 2018
    From the launch of a premarket digital safety program, to the release of new policies for multi-function device products, FDA Commissioner Scott Gottlieb made a plethora of announcements at the Health Datapalooza conference Thursday.

  • FDA Withdraws Final Rule to Cut Biologics Inspections

    • 04 May 2018
    The US Food and Drug Administration (FDA) on Friday withdrew a direct final rule that would have amended the general biologics regulations on inspection time requirements and would have removed inspector requirements.

  • MHRA Reveals 5-Year Plan, Seeks Clarity Post-Brexit

    • 24 April 2018
    A new five-year corporate plan the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) revealed Tuesday highlights how the agency intends to “become a real world regulator” and to “ensure a smooth EU exit under any scenario.”

  • Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    • 30 April 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.
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Recon
Recon: Accent Therapeutics Launches with $40M, J&J Drops Alzheimer’s Candidate
18 May 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
Recon: NICE Backs Roche’s Tecentriq for Routine Use in Pre-Treated Bladder Cancer Recon: Novartis Lawyer Exits Over Cohen Payments Recon: Celsius Snags $65M for Precision Medicines, Gilead to Build EU CART-T Facility
Regulatory News
Recon: Ebola Vaccine Arrives in DRC
21 May 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
FDA Proposes to Ease Regulatory Controls Over Software Used in Blood Establishments FDA, EMA Recommend Safety Precautions for ViiV HIV Drug Amgen Snags FDA Approval for Migraine Drug With $6900 Annual List Price
Feature Articles
FDA Regenerative Medicine Policy Framework and Advanced Therapy Designation
09 May 2018

This article discusses the policy framework established by the US Food and Drug Administration (FDA) for the regulation of regenerative medicine and advanced therapies. The four guidance documents supporting regenerative medicine regulation are summarized against the background of FDA's regulation of human cells, tissues and cellular and tissue-based products.

Temporary Importation of a Prescription Pharmaceutical Product Gene Therapy Harmonization Milestones and Challenges Expanded Access Policy Requirements, Orphan Drug Legislation and Gene Therapy Regulatory Challenges
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
30 April 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.

RAPS' Latest
Focus on: Daniela Drago
17 May 2018
A conversation with Daniela Drago, head of the regulatory affairs program at The George Washington University and chair of the RAPS DC/Baltimore Chapter, as part of our new Regulatory Focus interview series, ‘Focus on…,’ where we talk with regulatory leaders, thinkers and influencers from a variety of backgrounds.
Knowing Regulations Not Enough, Says Expert who Will Help Guide RAPS Exec Program Participants 8 Networking Tips for Regulatory Convergence Attendees RAPS, CAPRA Collaborate to Bring Canadian Regulators and Expertise to Global Audience
Trackers
FDA Advisory Committee Calendar
20 February 2018
Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.
Using Twitter as an Intelligence Tool: 85 Accounts Worth Following The Essential List of Regulatory Authorities in Asia The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech
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