• Regulatory NewsRegulatory News

    EMA reports slow uptick in clinical trial applications submitted via CTIS portal

    The number of applications filed through the Clinical Trial Information System (CTIS) portal continues to grow, even while most applications are still being filed in the current EudraCT system, according to a 28 July report from the European Medicines Agency (EMA).  Stakeholders offered a mixed assessment of their user experience at recent forum.   Starting in January 2023, CTIS will replace the EudraCT portal and clinical trial sponsors must use the CTIS portal to a...
  • Regulatory NewsRegulatory News

    EMA, HMA outline evolution of DARWIN EU real-world database

    The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) plan to launch an ambitious new database to collect real-world data (RWD) from a slew of studies that reviewers can reference for their regulatory decision-making.   Their joint Big Data Steering Group’s third workplan lays out a timeline to develop the Data Analysis and Real World Interrogation Network (DARWIN EU). According to the plan, by the end of this year, the research database will in...
  • Regulatory NewsRegulatory News

    Draft guidance: New options for submitting expedited safety reports for IND-exempt BA/BE studies

    The US Food and Drug Administration (FDA) has issued draft guidance providing instructions for how generic drug manufacturers can electronically submit expedited individual case safety reports (ICSRs) for serious adverse events through the FDA Adverse Event Reporting System (FAERS). The draft guidance , issued on 02 August, applies to investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies. Expedited safety reports for IND-exempt BA/BE st...
  • ReconRecon

    Recon: FDA to get less funding in Senate budget bill for FY 2023 compared to House version; EU funders fail to measure clinical trial transparency

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate Budget Draft Would Be Less Generous To US FDA Than House For FY 2023 ( The Pink Sheet ) ( Senate ) US FDA’s Project Site Selector Kicks Off With A Look At Why Cancer Trials Go Overseas ( The Pink Sheet ) FDA greenlights Marius; oral hypogonadism pill; VBL Therapeutics makes cuts to its workforce ( Endpoints ) Biden Names Monkeypox Coordinator as States ...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA focuses on continuous improvement in latest business plan

    Australia’s Therapeutic Goods Administration (TGA) has adopted four strategic objectives as part of its business plan for its 2022-23 financial year. The document sets TGA’s product regulation, stakeholder engagement and compliance and innovation agenda for the coming year.   One year ago, TGA listed product regulation and safety, regulatory reform, international engagement, and education and compliance as its priorities for 2021 and 2022. Those themes recur in the l...
  • Regulatory NewsRegulatory News

    Califf seeking Congressional assurance user fees won’t run out

    With only two months to go before user fee legislation runs out and no indication Congress will reauthorize it in time, FDA Commissioner Robert Califf sought to assure agency staff that he is doing his best to get certainty from lawmakers their jobs are not in jeopardy, according to a  letter to FDA employees dated 29 July.   “We are continuing to evaluate the situation, and to explore all potential options and scenarios,” said Califf. “Our latest estimates are that w...
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    FDA official: Patients play an increasing role in rare disease drug development

    Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful clinical benefits, according to Kerry Jo Lee, MD, associate director of rare diseases in the US Food and Drug Administration’s (FDA) Office of New Drugs (OND).   “Patients are increasingly recognized by all stakeholders as experts,” Lee said during a webinar on rare disease drug development hosted by the National Organization for Rare Disorders (NORD) on 27...
  • ReconRecon

    Recon: US makes $1.7 billion deal with Moderna for updated Covid booster; Sarepta plans to seek accelerated approval for Duchenne gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US   U.S. Reaches $1.74 Billion Deal With Moderna for Updated Covid-19 Shots ( Wall Street Journal ) ( The Pink Sheet ) ( Reuters ) Sarepta to seek early FDA approval for gene therapy to treat Duchenne muscular dystrophy ( STAT ) ( Fierce ) FDA’s Califf backs limited use of single-arm trials, but says regulatory pathways for some cancers should ‘move into a ne...
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    FDA clarifies reporting post-approval changes for disposable manufacturing materials

    The US Food and Drug Administration (FDA) on Friday issued a question-and-answer guidance  to provide clarity to manufacturers on reporting post-approval changes to disposable manufacturing material.   The guidance covers changes made to new drug applications (NDAs), biologics license applications (BLAs) or abbreviated new drug applications (ANDAs) and applies to all manufacturing establishments, including those that perform functions under contract.   During the...
  • Feature ArticlesFeature Articles

    A guide to finding the right mentor for regulatory career advancement

    All regulatory professionals share the same goal – to facilitate the commercialization of safe and effective products and services. However, accomplishing that goal and succeeding in this diverse discipline over the course of a career requires that one continuously adapt and pursue professional development opportunities. At an early career level, associates and specialists rely on their analytical skills, assessing technical documentation and practices against established ...
  • Regulatory NewsRegulatory News

    This Week at FDA: New guidance on disposable manufacturing materials, Generic Drug Cluster report

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, the US Food and Drug Administration (FDA) published a guidance that describes chemistry, manufacturing, and controls (CMC) postapproval changes related to disposable manufacturing materials that drug and biological product manufacturers can reference. The agency also publishe...
  • Feature ArticlesFeature Articles

    The mentor-mentee relationship: Surviving remote work

    Mentorship is an important aspect of professional growth. The COVID-19 pandemic disrupted how regulatory professionals interact with colleagues. This article discusses the benefits mentees and mentors gain from mentorship relationships and steps to consider when trying to build a mentor-mentee relationship – in-person or remote. It explores the dynamics of mentorship and its value for advancing a regulatory professional’s career.   Keywords – mentorship, networking,...