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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.
     

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  • 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.

  • 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 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: Boston Scientific to Buy BTG for £3.3B; MHRA Head Hudson to Step Down in 2019
20 November 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Genentech to Pay Immunocore $100M to Test MAGE-A4 Drug With Tecentriq Recon: FDA Expands Use of Seattle Genetics’ Adcetris Under Real-Time Review Pilot Recon: United Therapeutics Licenses Arena’s Ph. III PAH Drug for $800M
Regulatory News
EMA Warns of Impurity in Valsartan From Mylan
19 November 2018
The European Medicines Agency (EMA) on Monday announced the European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended the certificate of suitability to the monographs of the European Pharmacopeia (CEP) for Mylan Laboratories in Hyderabad, India.
 
FDA Works to Reduce Dog Testing in Drug Development Gottlieb, Woodcock Highlight FDA’s Efforts to Tackle Drug Shortages FDA Proposes New Framework on Prescription Drug-Related Software
Feature Articles
New Drug Price Transparency Requirements in Direct-to-Consumer Advertisements
20 November 2018
This article discusses the potential impact of an amendment to a US Senate healthcare spending bill that could require drug manufacturers to disclose their drug prices in all direct-to-consumer television advertisements.
Global IVD Regulations: Are they harmonized yet? LDT Regulation: Past, Present and Future A Comparative Study of US and EU Medical Device Regulations
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.

RAPS' Latest
RAPS Welcomes Utah Chapter
05 November 2018
Just over a year after a RAPS-affiliated local networking group was successfully established in Utah, the group officially became the RAPS Utah Chapter.
Making the Switch to Advertising and Promotion: My First 90 Days Looking Back at the 2018 Regulatory Convergence: the Newsworthy and Noteworthy RAPS Releases Results of Compensation Survey of Regulatory Professionals
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