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  • Regulatory NewsRegulatory News

    FDA: Digital safety data submission to supplant PDFs

    After a successful pilot program, the US Food and Drug Administration (FDA) is fine-tuning a transition to all-digital submission of safety data from clinical trials of investigational drugs.   The goal is to modernize the submission of regulatory data by shifting from use of multiple PDF documents into a digital submission format with structured data elements “that will allow us both to improve the data quality and also allow us to use new analytic tools,” to make oth...
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    EU agencies clarify pharmacovigilance expectations amid COVID-19

    In an update to their joint questions and answers document on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, the European Medicines Agency (EMA), European Commission and Heads of Medicines Agencies (HMA) expand on their expectations for pharmacovigilance.   The updated document features three new questions related to pharmacovigilance, covering topics from corrective and preventive actions management to pharmacovigila...
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    Pediatric anti-infective development addressed by FDA

    The US Food and Drug Administration (FDA) has issued new draft guidance for sponsors who are developing anti-infective drug products for the pediatric population.   The draft guidance notes that pediatric drug development in general comes with some challenges, including the fact that differences not only in body size but also organ maturation and body fluid composition and distribution can affect drug pharmacokinetics and pharmacodynamics in children. Also, some infect...
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    EMA revises methodological guidance for trials impacted by COVID-19

    Following a four-week public consultation, the European Medicines Agency (EMA) on Monday revised its guidance on methodological considerations for ongoing clinical trials amid the coronavirus disease (COVID-19) pandemic.   The agency also says it will extend its decision to hold all upcoming committee and working party meetings virtually through September 2020. The agency adds that it will continue its practice of holding stakeholder events virtually or postponing th...
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    EMA recommends eight new medicines, refuses one

    A committee of the European Medicines Agency (EMA) recommended that eight new medicines be approved at its June meeting, and issued a negative opinion on an anti-tumor drug.   The human medicines committee (CHMP) of EMA recommended a refusal of the marketing authorization for Daiichi Sankyo’s Turalio (pexidartinib), which was to be used to treat tenosynovial giant cell tumors. The agency cited concern for small improvement in clinical outcomes and uncertainty about dur...
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    FDA seeks input on genotyping for pediatric codeine use

    The US Food and Drug Administration (FDA) is seeking public consultation on whether children under the age of 12 years should be permitted to receive analgesics containing codeine, if they have been cleared from having a genetic tendency to metabolize the drug at potentially toxic levels.   Currently, the use of products containing codeine is contraindicated in children under the age of 12. Codeine, an opioid indicated for relief of mild to moderate pain under some cir...
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    EMA recommends remdesivir to treat COVID-19, authorization expected next week

    Following a rolling review that kicked off in late April, the European Medicines Agency (EMA) on Thursday recommended conditionally authorizing Gilead Sciences’ (Veklury) remdesivir to treat patients ages 12 and older with severe coronavirus disease (COVID-19) requiring supplemental oxygen.   EMA says it expects the European Commission to sign off on the conditional marketing authorization for remdesivir next week using a fast-track process, which will allow the drug t...
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    FDA gives Project Renewal update at AACR

    Generic cytotoxic cancer drugs are a cornerstone of cancer therapy, but their labels may not reflect current best evidence regarding safety and effectiveness. Progress on a pilot FDA effort to modernize labels for these drug was shared by Patricia Keegan, MD, acting associate director for medical policy at the FDA’s Oncology Center of Excellence, at the virtual annual meeting of the American Association for Cancer Research.    Project Renewal, begun at the end of 2018,...
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    FDA finalizes bacterial pneumonia drug development guidances

    The US Food and Drug Administration (FDA) on Wednesday finalized two guidances on developing drugs to treat community-acquired or hospital-acquired and ventilator-associated bacterial pneumonia.   Both guidances offer recommendations to sponsors on the development of drugs to treat bacterial pneumonia acquired in different settings and feature input on nonclinical development, trial population, efficacy trial considerations and other issues including pharmacokinetic/ph...
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    AACR: Minority accrual in clinical trials is a team sport

    Those who conduct clinical trials are missing a broad swath of the US population, with implications that not only reach into issues of equity and justice, but may also limit the generalizability of study findings, said a cancer researcher speaking at the American Association for Cancer Research annual meeting.   “Without adequate minority representation, it is difficult for us to fully be able to generalize the effects regarding the toxicity or efficacy or a medication...
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    EMA offers free orphan drug advising to academia

    Academic organizations working on drug development for rare diseases will now be eligible for waiver of fees for scientific advice from the European Medicines Agency (EMA), according to an updated Executive Decision issued by the agency. “The academic sector plays an important role in the development of innovative medicines. Their scientific research is often at the source of novel methodologies and innovative medicines with the potential to benefit patients with rare d...
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    New priorities set for trans-Atlantic collaboration on medicines

    As part of an annual bilateral regulatory dialog, officials from the European Commission (EC), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) agreed on priorities for collaboration.   “In the context of the  COVID-19 pandemic , the EC, EMA and FDA have further intensified their collaboration through regular interactions, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA),” said EMA in...