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  • RoundupsRoundups

    FDA Approvals Roundup: Fintepla, Dojolvi, Phesgo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Fintepla gets the go-ahead for Dravet syndrome Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.   The approval was based on findings from two clinical studies in 202 participants aged ...
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    Asia Regulatory Roundup: TGA ties fee increases to inflation, despite medtech opposition

    Australia’s Therapeutic Goods Administration (TGA) is set to increase its fees by 1.95% in its 2020-2021 fiscal year. TGA decided on the fee increase, which is tied to consumer price and wage inflation, despite a consultation revealing opposition from the medtech industry.   In January, TGA held a consultation to gather industry feedback on three options for changing its fees and charges. TGA stated its preferred option was a 1.95% increase, in line with an indexation ...
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    EU Regulatory Roundup: Regulators propose 40 actions to cut risk of medicine impurities

    European regulators have used their experience with the sartan contamination crisis to draw up a list of 40 recommendations for how to stop impurities from making their way into finished medicines.   Last year, members of the European regulatory network began considering the lessons learned from the discovery of N-nitrosamines in sartans and other classes of medicines. After receiving pushback from industry late last year, they have published a list of 40 recommendatio...
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    FDA Approvals Roundup: Tazverik, Crysvita, Xpovio

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Tazverik extended as therapy for mutated follicular lymphoma Epizyme’s Tazverik (tazemetostat) has been granted accelerated approval for treating adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved companion diagnostic, the cobas EZH2 Mutation Test (Roche...
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    Asia Regulatory Roundup: COVID-19 drives Australia to propose delay to medical device reforms

    Australian medical device reforms could be delayed until next year to give the industry more time to prepare, considering the effect COVID-19 has had on preparations.   Under the current timeline, Australia would implement a raft of reforms to its medical device rules on 25 August. If enacted, the delay will push the implementation of reforms to the regulation of medical device software and personalized medical devices back to 25 February 2021. The government is also p...
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    EU Regulatory Roundup: Noncompliance actions against Indian drugmakers drop to new low

    The number of European manufacturing noncompliance notices sent to Indian drugmakers fell to a new low last year, with just one good manufacturing practice (GMP) notice issued to an Indian company in 2019 compared to at least five annually over the previous four years, the European Medicines Agency (EMA) reported.   Indian drugmakers received a significant minority of all the GMP noncompliance notices issued by regulators in the European Economic Area (EEA) from 2015 t...
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    FDA Approvals Roundup: Zepzelca, Ilaris, Lyumjev

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Zepzelca handed accelerated approval for metastatic SCLC in adults Jazz Pharmaceuticals and PharmaMar’s Zepzelca (lurbinectedin) has been granted accelerated approval for adult patients with metastatic small cell lung cancer (SCLC) whose disease has progressed during or after platinum-based chemotherapy.   The indication was approved based o...
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    Asia Regulatory Roundup: Industry respondents urge TGA to align with international software regulations

    Respondents to a consultation by Australia’s Therapeutic Goods Administration (TGA) on the scope of regulations governing software as a medical device (SaMD) offered broad support for the regulatory scheme and the concept of carving out certain products to avoid undue regulatory burden, the administration reported on 15 June.   TGA held a consultation on the topic earlier this year, specifically to gather feedback on the types of software-based products that should and...
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    EU Regulatory Roundup: MHRA puts speed-to-market at center of post-Brexit vision

    Speed-to-market is the cornerstone of the 2020-2021 post-Brexit strategy for the UK Medicines and Healthcare products Regulatory Agency (MHRA), according to the agency’s business plan published 10 June 2020.   The UK left the European Union earlier this year but remains covered by its rules until the end of 2020. Unless the UK and EU agree to a delay by the end of June, the two parties will fully separate at the start of next year. Exactly how the separation happens wi...
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    FDA Approvals Roundup: Recarbrio

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   Recarbrio indication extended to pneumonia FDA has approved Merck’s Recarbrio (imipenem-cilastatin and relebactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial (HABP/VABP) pneumonia in patients aged 18 years or older.   The antibiotic was initially approved in 2019 for complicated urinary tract and intra-abdom...
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    Asia Regulatory Roundup: Medtech firms push back against TGA essential principles reform

    Australia’s Therapeutic Goods Administration (TGA) is reconsidering some aspects of proposed reforms to its essential principles for medical device safety and performance due to opposition from medtech organizations including Johnson & Johnson.   In September, TGA outlined plans to incorporate International Medical Device Regulators Forum (IMDRF) essential principles and European Union General Safety and Performance Requirements (GSPRs) into its own regulatory framewor...
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    EU Regulatory Roundup: Regulators to prioritize COVID-19 procedures if needed

    COVID-19 procedures will be prioritized if members of the European Medicines Regulatory Network (EMRN) cannot execute all activities, according to a business continuity plan developed by the European Medicines Agency (EMA) and the European Commission (EC).   The extent of capacity constraints defines the plan three-phase plan. In the first phase, members of EMRN can fulfill routine regulatory tasks for medicines authorized centrally and nationally. The third phase kicks...