• Regulatory NewsRegulatory News

    Tips for avoiding regulatory pitfalls in pediatric drug development

    Developers can improve their chances of success in getting pediatric drugs to market by consulting early with regulators in the US and the EU, understanding regulatory precedence and current context, and having a clearly defined clinical study design, experts advised at RAPS Convergence 2021.   One of the common hurdles in developing a pediatric drug product is navigating the different regulatory requirements in the US and Europe, said Linda McBride, a regulatory consu...
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    Convergence: How to navigate the US-Japan 'Harmonization by Doing' program

    Regulators from the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) discussed how medical device sponsors can get approval for global studies accepted into the regulators’ joint “harmonization by doing” (HBD) program.   The program is designed to save development time and costs in developing life-saving cardiovascular devices through the simultaneous review of global studies, explained Shin Iwamoto, a PMDA principal r...
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    Convergence: EMA study reveals need for RWE framework, submission structure

    The European Medicines Agency (EMA) has identified a need for more consistency in how real-world evidence (RWE) is submitted, Xavier Kurz told attendees at RAPS Convergence 2021.   Kurz, the head of surveillance and epidemiology at EMA, said the agency reached the conclusion after analyzing the use of RWE in applications for marketing authorization and extension of indication in 2018 and 2019. The study, preliminary findings from which were shared at RAPS Convergence 2...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA posts guide to rapid COVID-19 test performance requirements, risk mitigation strategies

    Australia’s Therapeutic Goods Administration (TGA) has provided guidance on performance requirements and risk mitigation strategies for rapid COVID-19 antigen tests ahead of its anticipated move to lift its ban on self-testing.   TGA disclosed plans to publish the guidance earlier this month in a call for expressions of interest in supplying self-tests in Australia. The guidance explains that rapid antigen tests, like the self-tests that Australia already allows unde...
  • ReconRecon

    Recon: CMS moves to end Trump-era MCIT rule; CureVac cuts vaccine productions plans

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden Covid team sees vaccine efficacy waning in unpublished data from Israel ( Politico ) Pioneering Gene Therapy Freed Her of Sickle Cell. Is a Cure at Hand? ( NYTimes ) Emergent to make Providence Therapeutics potential COVID-19 vaccine ( Reuters ) US judge grants Purdue Pharma's $7M exec bonus plan, faces blunt criticism ( Reuters ) Fourth boy dies in Ast...
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    Marks defends push toward COVID vaccine boosters

    Peter Marks, director of the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), defended the agency's moves toward authorizing third doses of COVID-19 vaccines amid their limited global supply.   Speaking at RAPS Convergence 2021 on Monday, Marks said he is "fully confident" that those who tune into the agency's upcoming advisory committee meeting to discuss Pfizer and BioNTech's supplemental biologics license application (sBLA...
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    Convergence: Regulatory considerations in advancing gene and cellular therapies

    When developing a regulatory submission for a gene or cellular therapy, it’s essential to keep the basics in mind, such as how to demonstrate the product’s identity, purity, and potency, Haroon Hashmi, PhD, told attendees at RAPS Convergence 2021.   “Even when we think about these complex technologies -- new emerging technologies -- certain regulatory principles always stay in place,” said Hashmi, senior vice president at Ziopharm Oncology, which has developed the Slee...
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    Convergence: First-year experience with Japan’s amended medical device rules

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is providing priority review for certain innovative medical devices and has implemented a post approval change management process to allow for continuous improvement of medical devices.   The changes are part of the Amendment of the Pharmaceutical and Medical Device Act (PMD Act), which was implemented in September 2020. Officials from Japan’s Ministry of Health, Labour and Welfare (MHLW) and the PMDA provided a...
  • ReconRecon

    Recon: UK launches trial of Grail blood test for 50 types of cancer; AbbVie hands Regenxbio $370M to develop gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA vaccine regulators argue against Covid-19 vaccine boosters in new international review ( STAT ) ( Endpoints ) ( NYTimes ) ( Politico ) GOP Seethes at Biden Mandate, Even in States Requiring Other Vaccines ( NYTimes ) Surgeon general: New vaccine policies neither illegal nor unusual ( Politico ) Novavax expects to make available at least 2 bln COVID-19 vacc...
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    Key regulators featured in RAPS Convergence 2021 health authority forums

    On Monday, RAPS Convergence 2021 attendees will have the opportunity to hear from global regulators during three health authority forums. The presentations will highlight key topics and updates relevant to each regulatory body in hour-long sessions.   The session featuring Japan’s Pharmaceutical and Medical Devices Agency (PMDA) features four Japanese regulators, including session leader Tetsuya Kusakabe, PMDA’s international coordination officer, and Kanako Sasaki, de...
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    Convergence: Plenary probes how FDA, EMA will move forward

    During the opening plenary session for RAPS Convergence 2021, leading regulators from the US and EU moved beyond the now-obligatory discussion of lessons learned from the pandemic to a substantive review of how the agencies are really faring a year and a half into the public health emergency of the COVID-19 pandemic.   Speaking to an audience of regulatory experts in attendance at the virtual conference, Janet Woodcock, acting commissioner of the US Food and Drug Admin...
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    Industry calls for withdrawal of FDA electronic tracing guidance

    Pharmaceutical distributors urge the US Food and Drug Administration (FDA) to immediately withdraw its guidance setting parameters for establishing electronic systems to trace products through the supply chain. A trade association for distributors claims the agency overreached its statutory authority in seeking access to private electronic tracing information among trading partners.   The guidance, published in June, laid the groundwork for the data architecture system...