• Regulatory NewsRegulatory News

    FDA Warns Chinese Sunscreen Manufacturer for Falsifying Documents

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research earlier this month sent a warning letter to China-based sunscreen and OTC drug manufacturer NingBo Huize Commodity Co. after the company’s general manager and quality manager admitted that multiple documents provided to FDA were falsified “for the purpose of this inspection.” FDA placed the firm on import alert in June and said that the firm agreed to recall all drug products distributed...
  • RoundupsRoundups

    Asia Regulatory Roundup: India to Add EU to List of Regions Covered by Clinical Trial Waiver

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Seeks Feedback on Mandatory use of QR Codes on API Packaging   India is planning to require manufacturers to feature quick response (QR) codes on the packaging of locally made and imported active pharmaceutical ingredients (API). The Indian government plans to implement the system at the start of April.   Through an amendment to the Drugs and Cosmetics Rule...
  • Regulatory NewsRegulatory News

    EC Adds IMQ as Fourth Notified Body Designated Under MDR

    The European Commission (EC) on Tuesday added Milan, Italy-based IMQ Istituto to its list of notified bodies (NBs) designated under the new Medical Devices Regulation (MDR). The announcement does not come as a surprise, as Italy’s Ministry of Health announced in late July that IMQ met the requirements of the regulation. The EC had also previously indicated in its rolling plan,  updated last Monday , that four NBs have been designated. The other three NBs to be de...
  • Regulatory NewsRegulatory News

    USP Consults on Impurity Reporting Threshold Changes

    The United States Pharmacopeia and National Formulary (USP-NF) last week launched a three-month public consultation on a proposal to change how impurity reporting thresholds for drug product and drug substance monographs are handled.   “As part of our commitment to ongoing monograph modernization, USP is updating organic impurities testing for articles subject to USP-NF standards,” USP writes, noting that its current approach relies on International Council for Harmoni...
  • Regulatory NewsRegulatory News

    FDA Warns Turkish Drugmaker Over Penicillin Cross-Contamination Issues

    The US Food and Drug Administration (FDA) warned Turkish drugmaker Deva Holding AS earlier this month over good manufacturing practice (GMP) violations at the company’s Tekirdağ manufacturing site.   The warning letter comes after a two-week inspection in February that identified a risk of penicillin cross-contamination between two adjacent campuses.   In July, FDA placed Deva on Import Alert and the company initiated a voluntary recall for all batches of six stren...
  • Regulatory NewsRegulatory News

    CDER Plots Pilot Project to Test CDISC Standard

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday said it will conduct a small pilot project to test the processing and analysis of nonclinical study data provided electronically using an updated standard, known as the SEND 3.1, from the Clinical Data Interchange Standards Consortium (CDISC). CDER is seeking a maximum of five participants for the pilot, which will evaluate the compliance of sample SEND 3.1 datasets subm...
  • Regulatory NewsRegulatory News

    Drugmakers Can Now Submit Pre-Assigned Number Requests via CDER’s Portal

    • 19 August 2019
    • By  
    Beginning Monday, prospective applicants can submit pre-assigned number requests for four additional application types: new drug application (NDA), investigational new drug (IND) application, biologic license application (BLA) and drug master file (DMF), via the Center for Drug Evaluation and Research (CDER)’s NextGen Portal.   The pre-assigned number requests were previously made via email. But now the firms submitting such applications can use the portal, which is a ...
  • ReconRecon

    Recon: FDA Rejects Vanda’s Jet Lag Drug; Roche and AbbVie Price New Cancer, RA Drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AbbVie prices new rheumatoid arthritis drug at $59,000 a year ( Reuters ) Roche cancer treatment priced at $17,050 a month, lower than rival Vitrakv ( Reuters ) Minority racial groups continue to be dismally represented in cancer trials ( Endpoints ) ( STAT ) ( JAMA ) Vanda shares slide after FDA spurns their big endpoint and rejects a pitch on jet lag relief ...
  • Regulatory NewsRegulatory News

    APEC Members See Increased Regulatory Convergence

    Countries involved in the Asia-Pacific Economic Cooperation (APEC) are better aligning their regulatory schemes related to drugs and medical devices, according to a new survey unveiled Monday at an APEC meeting in Chile. The survey shows how between 2008 and 2019, APEC countries are seeing modest increases in: Sharing information (from 16 APEC economies to 19 economies) Establishing confidentiality commitments (from 12 economies to 15) Sharing good manufacturing pr...
  • Regulatory NewsRegulatory News

    Here Come the Oncology Biosimilars in the US: How Low Will Prices Go?

    A quick look at biopharma’s top-selling drugs (including forecasted sales through 2024) reveals a trio of biologic cancer treatments that have been marketed since 1997 and will likely bring in a cumulative total of more than $300 billion. But biosimilar competition for Roche’s Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan (rituximab) is now ready to launch in the US, and Bernstein biopharma analyst Ronny Gal said in a report issued Friday that prices over...
  • Regulatory NewsRegulatory News

    MDIC Kicks Off Framework on Patient Input in Device Trials

    The nonprofit Medical Device Innovation Consortium (MDIC) is seeking comments on the first of three resources to support its Framework for Patient Input in Medical Device Clinical Trials, which is set to be complete next year. Overall, MDIC seeks to use this framework to better integrate patient input and preferences into the design of device trials and seek to reduce the burden on patients participating in such trials. The white paper published Wednesday, which is o...
  • Regulatory NewsRegulatory News

    Generic Drug Approvals Hit Another Record High as Competition, Quality Questions Linger

    Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA). This has been the story at FDA from FY 2016 to FY 2017 to FY 2018 and now to FY 2019 , with two months to spare. But questions remain on whether these approvals are actually translating into greater competition and lower costs for patients. A report from Pew earlier this year found that the increase in approved generic drugs fr...