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  • Regulatory NewsRegulatory News

    Patient-Focused Drug Development: New FDA Draft Guidance Delves Into What’s Important

    The US Food and Drug Administration (FDA) on Monday published the second in a series of four guidance documents on patient-focused drug development, with this latest draft helping sponsors identify what is most important to patients with respect to their experience with disease burden and treatment. In determining what’s important, FDA recommends that sponsors use qualitative research methods, which can generate in-depth thoughts from patients in their own words through...
  • ReconRecon

    Recon: Lundbeck Buys Alder for $2B; Purdue Pharma Files for Bankruptcy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US First peanut allergy treatment gains backing from FDA advisory panel ( Science ) ( Atlantic ) ( AP ) Purdue Pharma, maker of OxyContin and other drugs, files for bankruptcy ( Stat ) ( Bloomberg ) ( WSJ ) ( Guardian ) Opioid Defendants Seek to Disqualify Judge Overseeing 2,300 Cases ( NY Times ) The Startup That Manipulated Data to Get a Miracle Drug to Market ...
  • Regulatory NewsRegulatory News

    EMA, FDA Begin Reviewing Heartburn Medicines for Carcinogen

    Following its investigation into an impurity called N-nitrosodimethylamine (NDMA) in blood pressure medicines, the European Medicines Agency (EMA) on Friday said that, at the request of the European Commission, it’s beginning a review of ranitidine medicines after tests showed that some contained the impurity. NDMA is classified as a substance that could cause cancer on the basis of animal studies, although EMA explains how it is present in some foods and in water suppl...
  • RoundupsRoundups

    EU Regulatory Roundup: ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work   The European Parliament’s health committee has renewed its call for the region’s drug regulator to be given more money and staff. ENVI, the Committee on the Environment, Public Health and Food Safety, made the comment in its opinion about the European Union’s 2020 budget proposal.   Pascal Ca...
  • Regulatory NewsRegulatory News

    Study Finds Extent of Unvalidated Surrogate Endpoint Use in Expedited Approvals ‘Concerning’

    Research published this week in PLOS Medicine raises concerns about the use of surrogate endpoints to support the marketing authorizations of products assessed via the European Medicines Agency’s (EMA) conditional marketing authorisation (CMA) and accelerated assessment (AA) pathways. The use of the CMA and AA pathways, which is restricted to situations of “unmet medical need” and/or “in the interests of public health,” are often based on incomplete benefit-risk asses...
  • RoundupsRoundups

    EU Regulatory Roundup: Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System   Ireland has extended the “use and learn” phase of the implementation of the Falsified Medicines Directive (FMD) for a second time. The implementation phase will now end in a staggered manner starting sometime after the end of September.   When the FMD safety feature requirements ca...
  • RoundupsRoundups

    EU Regulatory Roundup: AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit   The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has added the active pharmaceutical ingredient (API) in AstraZeneca’s Calquence to the list of materials cleared for export to the European Union in the event of a no-deal Brexit.   If the UK leaves without a deal the E...
  • Regulatory NewsRegulatory News

    EMA Offers Q&A on Exemptions From Batch Re-Testing for Imported ATMPs

    The question and answer (Q&A) document released by the European Medicines Agency (EMA) on Wednesday describes when an exemption from EU batch re-testing can be granted for imported advanced therapy medicinal products (ATMPs). The three-page Q&A begins by noting that a Qualified Person (QP) has to ensure each batch of imported ATMP is re-tested upon importation. But the QP can certify that the imported batch relies on controls conducted in a third country if the product ...
  • Regulatory NewsRegulatory News

    EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016. In just eight of the 107 applications, FDA initially declined to approve a new drug or biologic while EMA approved it, although in all eight of those cases, FDA ended up approving that drug or biologic. And in one case ...
  • Regulatory NewsRegulatory News

    FDA-EMA Workshop Discusses Quality Challenges for PRIME, Breakthrough Therapies

    Last November, officials from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) met with industry representatives in London to discuss the various quality challenges that arise when the development of investigational products is accelerated. EMA’s launch of its priority medicines (PRIME) scheme and FDA’s breakthrough therapy designation have enabled companies to speed certain treatments to market, although there have been difficulties in ...
  • Regulatory NewsRegulatory News

    Novartis’ Zolgensma Joins Growing List of Medicines to Lose Accelerated Assessment Status in EU

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently announced its decision to remove Novartis’ spinal muscular atrophy gene therapy onasemnogene abeparvovec from its accelerated assessment program. CHMP did not announce its reasoning behind the decision, which effectively means that the treatment, approved in the US as Zolgensma and launched at a price of more than $2 million, will be reviewed in the EU in 210 days rather...
  • Regulatory NewsRegulatory News

    EMA Recommends Conditional Approval for First Tissue-Agnostic Cancer Treatment

    The European Medicines Agency’s (EMA) human medicines committee (CHMP) on Friday recommended the conditional approval for the first medicine to treat tumors with a specific mutation, regardless of where in the body the tumor originated.   Bayer’s Vitrakvi (larotrectinib) is as a treatment of adult and pediatric patients with solid tumors that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, according to EMA. Treatment with Vitrakvi is recommended for ...