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  • Regulatory NewsRegulatory News

    FDA recalls some ER metformin for NDMA impurity

    Some extended-release formulations of the diabetes drug metformin contained levels of a nitrosamine impurity falling above the US Food and Drug Administration’s (FDA’s) acceptable intake limit, according to recent testing conducted by the agency.   Several lots of extended-release (ER) metformin tested above the acceptable limit for N-nicrosodimethalymine (NDMA), set by the FDA at 96 nanograms per day for drugs. The substance is ingested in low levels through normal di...
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    FDA seeks input on rare disease clinical trials network

    To further the establishment of a rare disease clinical trials network, the US Food and Drug Administration (FDA) is asking for input from the public and a broad array of stakeholders.   In a press release, the agency noted that it is “looking to provide a more cooperative approach” in supporting the drug development pipeline for rare diseases.   The call for information comes as the FDA is launching a Rare Disease Cures Accelerator . This accelerator will establi...
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    Interview: FDA’s Cohen on OTC naloxone labeling study

    An over-the-counter formulation (OTC) of naloxone could expand the availability of a life-saving tool in addressing the opioid crisis, since the medication can rapidly and safely reverse opioid overdose. The US Food and Drug Administration (FDA) has developed a model consumer label for OTC naloxone and conducted a consumer behavior study; these results were published this week in the New England Journal of Medicine .   RELATED: FDA labeling study helps clear path...
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    Health Canada releases guidance to streamline COVID-19 clinical trials

    Health Canada Wednesday issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19.   The guidance documents support an interim order (IO) that reduces the administrative burden of clinical trials and promotes efficient investigation of drugs and medical devices to treat, prevent, mitigate or diagnose COVID-19.   The IO has dropped administrative requirements for non-significant changes during a...
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    FDA labeling study helps clear path for OTC naloxone

    Consumers reading a model drug facts label for naloxone could understand labeling sufficiently to use the opioid antagonist safely and effectively without the support of a healthcare provider, according to a label-comprehension study conducted by the US Food and Drug Administration (FDA).   The unusual move by the FDA could help clear a hurdle to approval of over-the-counter injectable and intranasal naloxone; many public health experts concerned about the impact of th...
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    FDA warns South Korean firm for inadequate training, insufficient personnel monitoring

    A South Korean drug manufacturing firm was cited by the US Food and Drug Administration for having insufficiently trained personnel and for insufficient monitoring of aseptic processing areas.   The deficiencies were detected in an October 2019 FDA inspection of Samchundang Pharm’s Hwaseong facility. The agency found that Samchundang failed to establish the suitability of the sterility test method it used for final release of its drug products and also didn’t determi...
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    New York ophthalmic drugmaker cited for environmental and data integrity issues

    The US Food and Drug Administration (FDA) has warned a New York based pharmaceutical company for data falsification and failing to establish adequate monitoring in aseptic processing areas.   The firm, Altaire Pharmaceuticals, manufactures sterile ophthalmic drug products, as well as over the counter ophthalmic and homoeopathic products.   In its warning letter dated 12 March 2020, the FDA detailed findings from a 2019 inspection, where inspectors found that the ...
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    FDA consults on ICH residual solvents update

    The US Food and Drug Administration (FDA) on Tuesday launched a two-month public consultation on an International Council for Harmonisation (ICH) guideline establishing new permitted daily exposures (PDEs) for three residual solvents.   Specifically, the ICH Q3C(R8) guideline is a product of the maintenance procedure for updating ICH’s guideline for residual solvents as new toxicological data for become available. The eighth revision to the guideline adds PDEs for thre...
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    EMA strengthens ENCePP mandate to address COVID-19 pandemic

    The European Medicines Agency (EMA) has strengthened the mandate for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), creating a COVID-19 Response Group working within ENCePP to aid in pharmacovigilance and pharmacoepidemiology work amid the pandemic. EMA said the new mandate is necessary to address “unprecedented challenges for the epidemiological and regulatory communities” in addressing COVID-19. “This role would give ENCePP ...
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    FDA updates COVID-19 compounding guidance with reporting clarification

    Two guidance documents related to compounding drugs during the coronavirus pandemic were updated by the US Food and Drug Administration (FDA) on Thursday. Among other updates, a requirement for weekly reporting will allow hospitals to identify which compounders are making what quantities of drugs currently in shortage during the public health emergency of the COVID-19 pandemic.   The FDA updated two separate guidance documents regarding compounding of fifteen drugs tha...
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    MHRA launches dedicated COVID-19 Yellow Card site

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday launched a dedicated site for reporting side effects and incidents related to medicines and medical devices used in patients infected with SARS-CoV-2, the novel coronavirus that causes COVID-19.   The COVID-19 Yellow Card reporting site is meant to “enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects ...
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    Multinational efforts build framework for real-world and observational COVID-19 data

    International regulators will increase cooperation for observational studies conducted in three key eras during the coronavirus pandemic.   Building a strong infrastructure to monitor vaccine safety and effectiveness, putting together international clinical cohorts of patients with COVID-19 infection and pregnancy research were identified as priority areas for cooperation during a workshop held 19 May 2020 under the umbrella International Coalition of Medicines Regulat...