• Regulatory NewsRegulatory News

    Medical Device Premarket Cybersecurity: TGA Finalizes Guidance

    The premarket requirements on medical device cybersecurity from Australia’s Therapeutic Goods Administration (TGA) came into effect on Thursday, with new details that further underscore the agency’s push for the total product lifecycle (TPLC) approach and international harmonization.   A 53-page final guidance sets the premarket cybersecurity requirements on manufacturers and sponsors of medical devices and in vitro diagnostic devices. Requirements are centered on es...
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    India’s New Drugs and Clinical Trials Rules: An Industry Perspective

    This article highlights the recently published, revised regulatory pathway in India and focuses on the regulatory changes and their impact on industry and on clinical trials. The authors discuss product registration, changes to clinical trials rules, revisions to “new drug” definitions, postmarketing studies, orphan drug registration, ethics committees, fees and waivers and the importation and manufacture of unapproved new drugs.   Introduction   India’s Ministry o...
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    FDA Discusses RWD, RWE With Industry, Academia

    Industry, academia and US Food and Drug Administration (FDA) officials gathered Friday in Bethesda, MD to discuss the use of real-world data (RWD) and real-world evidence (RWE) in the premarket and postmarket settings. Jacqueline Corrigan-Curay, director of CDER’s Office of Medical Policy, kicked off the joint FDA-American Association for Cancer Research meeting to discuss FDA’s framework for using RWE, which was unveiled in December 2018 . The framework is meant to gu...
  • ReconRecon

    Recon: Amgen and Allergan Launch Avastin and Herceptin Biosimilars

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amgen and Allergan Launch Mvasi and Kanjinti, the First Anticancer Biosimilars, in the United States ( Center for Biosimilars ) ( Endpoints ) ( Fierce ) ( Press ) Canada warns US against drug import plans, citing shortage concerns ( Reuters ) Biotech enters an era of ‘platform’ dominance ( STAT ) Second opioid distributor charged over role in US drug epidemic ...
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    EU Ombudsman Concludes Inquiry on EMA Interactions With Medicine Developers

    The EU ombudsman this week said that it believes that the European Medicines Agency (EMA) should not allow the same experts to provide scientific advice to medicine developers prior to an application and evaluate the same medicine, claiming such overlap runs the risk of damaging impartiality or creating the perception of bias. In response to the comments, following a two-year inquiry into EMA’s interactions with drug developers, EMA said Friday: “Early interactions with...
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    FDA Validates Streamlined Review of SaMD Under PreCert Pilot

    In a Thursday update on the US Food and Drug Administration’s (FDA) Precertification (PreCert) pilot program for software as a medical device (SaMD), the Center for Devices and Radiological Health (CDRH) said retrospective testing supported the streamlined review of SaMD.   CDRH’s PreCert team retrospectively tested previously reviewed submissions in May to see if the accelerated review pathway tailored to SaMD products provides the same level of reasonable assurance o...
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    FDA Offers Technical Specifications for Submitting NGS Data on Antivirals

    The US Food and Drug Administration (FDA) on Thursday published a technical specifications document to help sponsors submit next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drugs. The guidance explains how next generation sequencing (NGS) “adds complexity to the resistance analysis process,” which can make it challenging for reviewers “to analyze and validate the sequence information p...
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    FDA to Study Physicians’ Interpretations of Drug Information

    The US Food and Drug Administration (FDA) on Thursday said its Office of Prescription Drug Promotion (OPDP) will conduct a study to determine how factors such as information source, graphical presentations and time can influence physicians’ interpretation of information about prescription drugs presented in scientific journals versus promotional materials.   The study will also look at how the level of methodological rigor of the underlying data impacts physicians’ int...
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    Patient Registries May Prove Valuable in Regulatory Decisions, EMA Study Finds

    Although patient registries can be heterogenous in their quality and design, a new study in Drug Safety co-authored by a European Medicines Agency (EMA) official explains how patient registries could provide valuable data for regulatory decisions. The authors explain how such registries can be used when randomized controlled trials are not feasible, such as with some rare diseases, or to meet postmarketing commitments. “For products granted conditional marketing ap...
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    Office of Generic Drugs Explains Research Conducted in First Year of GDUFA II

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Thursday released a report on the two dozen research grants awarded related to complex generics in 2018, as well as the research done in seven other areas, including data analytics and combination products.  Thanks to the second iteration of the Generic Drug User Fee Amendment (GDUFA II), OGD was able to turn its research and scientific activities into 136 new product-specific guidances (PSGs...
  • ReconRecon

    Recon: Novartis Sets Aside $700M to Settle US Bribery Suit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis Sets Aside $700 Million to Settle Bribery Allegations ( WSJ ) ( STAT ) ( Reuters ) Fraud conviction of ‘pharma bro’ Martin Shkreli upheld by federal appeals court ( CNBC ) Kronos, a startup led by Gilead alumni, raises $105 million in latest mega-round ( STAT ) Elizabeth Holmes Wins Judge’s Backing in Getting FDA Documents Faster ( Bloomberg ) ( Law36...
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    EU Regulatory Roundup: UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation   Committees of British politicians have pushed back against the government’s attempts to adopt new drug and medical device legislation without holding debates in Parliament.   Last month, the UK government proposed changes to legislation intended to ensure the rules covering dru...