Search News & Articles
Today
Today
  • FEATURED STORY
    Story Thumbnail
    Feature ArticlesFeature Articles

    FDA’s Oncology Clinical Trial Makeover

    • 12 February 2019
    This article provides an overview of new FDA guidances related to oncology drug development and a review of pilot programs aiding faster access to new, innovative treatments without increasing risk to patients.
  • Regulatory NewsRegulatory News

    FDA Warns of Increased Risk of Death With Gout Medicine Uloric

    • 22 February 2019
    The US Food and Drug Administration (FDA) on Thursday said it has concluded there is an increased risk of death with Takeda’s Uloric (febuxostat) when compared to another gout medicine, allopurinol, and the agency added a boxed warning to Uloric.
     
  • Regulatory NewsRegulatory News

    Catalyst Defends $375,000 Price Tag for Previously Free Drug

    • 21 February 2019
    In response to questions from Sen. Bernie Sanders (I-VT) on the price tag of a new orphan drug, Catalyst Pharmaceuticals on Thursday explained how much it had to invest in Firdapse (amifampridine) to bring it to market and how the previously experimental version of the drug should not be the standard of care.
     
  • Regulatory NewsRegulatory News

    Final FDA Rule to Require Foreign Device GCP Compliance Comes into Effect

    • 21 February 2019
    The US Food and Drug Administration (FDA) final rule that requires foreign clinical investigations for medical devices to comply with good clinical practice (GCP) requirements came into effect on Thursday.  
     
  • Regulatory NewsRegulatory News

    FDA Proposes New Rule for Sunscreen Products

    • 21 February 2019
    The US Food and Drug Administration (FDA) proposed a new rule on Thursday to update regulatory requirements for most sunscreen active ingredients currently on the US market.
     
  • Regulatory NewsRegulatory News

    EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials

    • 21 February 2019
    The European Medicines Agency (EMA) on Thursday opened for consultation a new guideline on the structure and data requirements for a clinical trial application for exploratory and confirmatory trials with advanced therapy investigational medicinal products (ATIMPs).
     
  • Regulatory NewsRegulatory News

    FDA Offers Guidance on Nicotine Replacement Therapies

    • 21 February 2019
    The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations to drugmakers looking to develop nicotine replacement therapy (NRT) products to help patients quit smoking.
  • Regulatory NewsRegulatory News

    Swissmedic Begins Working With EudraGMDP Database

    • 21 February 2019
    As part of the mutual recognition agreement between the EU and Switzerland, the Swiss Agency for Therapeutic Products (Swissmedic) has begun entering information on good manufacturing practice (GMP) compliance and manufacturing authorizations into the EU’s EudraGMDP database.
     

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe

Most Viewed Articles

Regulatory Focus ArticlesRSS 2.0
Recon
Recon: AbbVie Adds Parkinson’s Gene Therapy to Voyager Pact; Sanofi Says it Gave Payers $12B in Rebates in 2018
22 February 2019
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: AbbVie Adds Parkinson’s Gene Therapy to Voyager Pact; Sanofi Says it Gave Payers $12B in Rebates in 2018 Recon: Merck Acquires Immune Design for $300M; CMS Projects US Health Spending to Rise 5.5% Annually Over the Next Decade Recon: EMA Loses Bid to End London Lease; Merck’s Keytruda Fails Late-Stage Liver Cancer Study
Regulatory News
Generic Drugs: FDA Releases 74 Product-Specific Guidances
22 February 2019
As part of its push to increase generic competition, the US Food and Drug Administration (FDA) on Friday published 74 product-specific guidances, including 22 new and 52 revised guidances.
 
Generic Drugs: FDA Releases 74 Product-Specific Guidances CDRH Issues Guidance on Brain-computer Interface Devices FDA Defends its Efforts to Ensure Generic Drug Quality
Feature Articles
Regulatory Intelligence Communication for Business Impact
18 February 2019
This article focuses on maximizing Regulatory Intelligence (RI) in response to specific stakeholder requests and offers best practices recommendations for RI communication.
Regulatory Intelligence Communication for Business Impact The Emerging Role of Artificial Intelligence in Healthcare Risk Management Comes of Age. Have we?
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
21 February 2019
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

regulatory-focus-(1).png

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 Opens Board of Directors Nominations
12 February 2019
Today, RAPS opened the call for nominations for three vacant positions on the 2020–22 term of its board of directors. RAPS is seeking qualified candidates to fill the roles of president-elect, treasurer and one director position. Nominations will be accepted now through 29 March.
RAPS Opens Board of Directors Nominations 235 Earn Regulatory Affairs Certification (RAC) Focus on: Don Boyer
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.
Preparing for successful meetings with the FDA The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems
Latest Tweets