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  • Regulatory NewsRegulatory News

    Euro Regulatory Roundup: EU health committee calls for EMA to get wider remit, more staff to stop shortages

    A key health committee has called for the European Medicines Agency (EMA) to get a wider remit and an increased headcount to prevent shortages of essential medicines. The European Parliament committee made the request in a report that argues EMA should be made the regulatory authority in charge of preventing shortages.   In recent months, multiple Parliament committees have begun considering how to address the emerging problem of medicine shortages. As the group primar...
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    FDA adds three tropical diseases to PRV list, rejects two

    Three new conditions were added today to the list of tropical diseases for purposes of obtaining a tropical disease Priority Review Voucher (PRV) from the US Food and Drug Administration (FDA). The agency added brucellosis to the list, as well as two foodborne trematode infections, opisthorchiasis and paragonimiasis.   The agency determined that two other diseases, coccidioidomycosis and clonarchiasis, did not meet statutory criteria for tropical disease designation un...
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    FDA updates COVID-19 therapeutics website

    The US Food and Drug Administration (FDA) has to date reviewed over 230 trials of potential therapeutics to treat the novel coronavirus (COVID-19), according to a blog post by FDA commissioner Stephen Hahn, MD and colleagues. Over 510 COVID-19-directed drug development programs have reached the planning stage.   In the blog, agency officials provide an update on FDA’s Coronavirus Treatment Acceleration Program (CTAP), a set of resources designed to allow cross-agency...
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    Asia-Pacific Regulatory Roundup: TGA grants provisional approval to Gilead’s COVID-19 drug remdesivir

    Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Gilead Sciences’ remdesivir for use in adults and adolescents hospitalized with severe COVID-19 symptoms.   Like its international peers, TGA sought to fast track its review of remdesivir to get the antiviral to patients as quickly as possible. TGA said it made a decision within two weeks of receiving a filing for approval of the drug, which is sold under the brand name Veklury, by h...
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    Industry calls for IP protection, innovation support in EC pharmaceutical roadmap

    The European Commission (EC) has posted feedback it received on a new roadmap for a pharmaceutical strategy aimed at increasing timely patient access to affordable medicines. The feedback period began 16 June; a period of public consultation remains open until 15 September, with commission adoption planned for the 4 th quarter of 2020. Organizations leaving feedback generally welcomed the development of the roadmap, but many pharmaceutical manufacturers and trade assoc...
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    EU agencies urge sponsors to ensure post-Brexit compliance with clinical trial rules

    In a notice issued on Thursday, the European Commission, European Medicines Agency and Heads of Medicines Agencies reminded clinical trial sponsors that they must comply with EU clinical trial rules following the Brexit transition period that expires on 31 December 2020.   With the deadline to extend the transition period now passed, “There is no possibility for further extension beyond that date,” the agencies write, pointing trial sponsors to the Commission’s Brexit ...
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    FDA finalizes guidance on broader cancer trial eligibility

    In four final guidances published today, the US Food and Drug Administration (FDA) outlines cancer trial eligibility criteria considerations for individuals with several specific clinical conditions. Another guidance addresses minimum age considerations for inclusion of pediatric patients in cancer clinical trials.   The guidances, issued jointly by FDA’s Centers for Drug Evaluation and Research and Biologics Evaluation and Research (CDER and CBER), provide considerati...
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    More metformin recalled for NDMA; 6 firms now affected

    Two manufacturers have announced voluntary recalls of metformin formulations containing elevated levels of a potential carcinogen.   Granules Pharmaceuticals, based in Virginia, has issued a recall for its extended-release metformin, although just one of 12 batches tested exceeded acceptable levels of N-nitrosodimethylamine (NDMA) in the firm’s testing. The recall includes 100- and 500-count bottles of 750 mg metformin tablets.   Separately, India-based Lupin Pha...
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    Unified agenda: FDA publishes lengthy to-do list

    Two final rules top the Spring 2020 regulatory agenda for the US Food and Drug Administration (FDA), addressing the importation of prescription drugs and the de novo classification process for medical devices. The agency’s unified agenda overall is mammoth and includes 26 final rules as well as 52 proposed rules, some of which have been carried over from previous agendas.   The importation of prescription drugs continues to be among deregulatory priorities for the Tr...
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    FDA clarifies informed consent provisions in COVID-19 clinical guidance

    The US Food and Drug Administration (FDA) last week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to clarify how sponsors can obtain informed consent from patients in isolation or who can receive electronic copies of informed consent documents but due to time constraints cannot print or electronically sign the documents.   The guidance , which has been updated frequently as more questions arise from sponsors during...
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    EMA, HMA consult on next 5-year network strategy

    The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) on Monday released their next five-year network strategy aimed at steering the regulators through a “time of rapid charge” for a two-month public consultation .   The 46-page European medicines agencies network strategy to 2025 sets out six priorities for the regulatory network in the post-coronavirus era and follows the agencies’ previous network strategy to 2020. (RELATED: EU regulators ...
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    FDA asks stakeholders to join PDUFA talks by 17 August

    The US Food and Drug Administration (FDA) on Monday called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Prescription Drug User Fee Act program by 17 August 2020.   The monthly periodic consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin the following month.   The call...