• ReconRecon

    Recon: US Supreme Court to take up Amgen patent case; Monoclonal antibody for RSV gets EMA approval

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. Supreme Court gives Amgen a boost by agreeing to review a closely watched patent case ( STAT ) ( Reuters ) FDA Requirements For Next Round Of COVID Vaccines Unclear ( Pink Sheet ) Pfizer, BioNTech data support new Covid booster’s advantage over original vaccine ( BioPharma Dive ) What Will USPTO-FDA Collaboration Look Like? Stakeholders To Weigh In On Pro...
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    Pandemic highlighted challenges of ATMP clinical trials in Europe

    AMSTERDAM - A conflict between European regulations governing clinical trials and those governing the use of genetically modified organisms (GMO) was distinctly exposed by the COVID-19 pandemic, Charlie Mortazavi said here at RAPS Euro Convergence.   That attention and future clarification of the regulations could help clear the way for clinical trials of advanced therapy medicinal products (ATMP) in Europe, said Mortazavi, senior manager of global regulatory affairs a...
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    Changes to pediatric, orphan drug regulations on European horizon

    AMSTERDAM - As regulators craft revisions to the European regulations governing pediatric and orphan drug development, the time is now for stakeholders to gather their thoughts and prepare their comments aimed at improving the impending draft documents.   That was the message that Karl-Heinz Huemer of the scientific office at the Austrian Medicines Agency (AGES) brought to delegates at RAPS Euro Convergence.   The European Paediatric Regulation 1901/2006 and amen...
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    Recon: FDA mulls second COVID booster; GSK pauses some RSV vax trials

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Eyes Second Covid-19 Booster Shot ( WSJ ) Pfizer’s Covid-19 Vaccine for Kids Isn’t Working Well Against Omicron So Far, Delaying FDA Review ( WSJ ) FDA Looking For A Few Good Contractors To Guide Digital Modernization ( Medtech Insight ) Still Mulling EUA Transition Options? Don’t Wait Too Long, Attorney Says ( Medtech Insight ) Teva takes 'skinny' label ...
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    MCIT: Not a better way to pay for breakthrough devices

    The Medicare Coverage of Innovative Technology (MCIT) pathway should be rescinded because it does not require thorough evidence of the safety and efficacy of the medical device for which it aims to provide coverage, Vinay K. Rathi, MD, of Harvard Medical School and colleagues wrote in a perspective published in the New England Journal of Medicine .   MCIT would provide up to four years of Medicare coverage for medical devices authorized under the US Food and Drug Admi...
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    Perspective: Drug price transparency in the Biden era

    The Trump administration’s efforts to increase drug price transparency are likely to survive the transition to the Biden administration, according to a perspective piece published 13 January in the New England Journal of Medicine . Included in the Transparency in Coverage final rule, issued in late October 2020, the drug price transparency provisions aim to require that health insurers publish list prices and historical net prices for prescription drugs. The inform...
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    EUAs are evolving for the better, expert writes

    Lessons learned from early COVID-19 emergency use authorizations (EUAs) granted by the US Food and Drug Administration (FDA) could go far to improve public trust in a future EUA or approval of a vaccine – and in the regulatory process itself, Herschel Nachlis writes in the Health Affairs Blog. While FDA has suffered some potential missteps – such as the now-revoked hydroxychloroquine EUA – and problematic political pressure on its process, the agency has improved its ...
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    Breast implant label guidance finalized by FDA

    Updated 29 September to add comment from CDRH official The US Food and Drug Administration (FDA) issued final guidance on improving patient information regarding breast implants on 28 September. The final guidance largely echoes draft labeling guidance issued in October 2019, with some clarifications surrounding the relationship between implants and systemic disease, language to improve the readability of the patient device card, and information on specific registries...
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    COVID-19 vaccine: Experts warn of waning public confidence

    Conflicting messages and priorities between vaccine makers and federal leaders serve only to exacerbate public mistrust of potential COVID-19 vaccines, according to a perspective piece from Harvard professors published in the New England Journal of Medicine .   Jerry Avorn, MD, and Aaron Kesselheim, MD, both from the division of pharmacoepidemiology and pharmacoeconomics at Harvard Medical School, took to the august publication to share their thoughts on the juxtaposi...
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    FDA explains transfer of ownership policy for generics

    The US Food and Drug Administration (FDA) has issued a new manual of policies and procedures (MAPP) for transferring ownership of drug applications, including those due to corporate mergers and acquisitions.   The new MAPP outlines how Orange Book staff in the Office of Generic Drugs will process requests to transfer ownership of a drug application and explains the responsibilities of the current owner of the drug application as well as the new owner.   To transf...
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    FDA qualifies decision tool for breast reconstruction studies

    The BREAST-Q Reconstruction Module now is qualified as a medical device development tool (MDDT) to aid sponsors and investigators in developing feasibility, pivotal and post-approval studies of medical devices used in breast reconstruction, the US Food and Drug Administration (FDA) announced. “An MDDT is scientifically validated and can be qualified for use in device evaluation and to support regulatory decision-making,” according to the announcement , which noted its ...
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    FDA touts advanced manufacturing to address COVID shortfalls

    Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the COVID-19 pandemic, Stephan Hahn, Food and Drug Administration (FDA) commissioner, and Anand Shah, FDA deputy commissioner for medical and scientific affairs, wrote in a blog post on the FDA website. “The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, whic...