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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    UK grants early access to remdesivir for COVID-19

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued a positive early access to medicines scheme (EAMS) opinion for Gilead Sciences’ remdesivir to provide the drug via the National Health Service to certain hospitalized patients with severe cases of coronavirus disease (COVID-19).   “For the time being and due to limited supplies, treatment will be prioritised for patients who have the greatest likelihood of deriving the most benefit,” ...
  • RoundupsRoundups

    Asia Regulatory Roundup: India acts to stop hoarding of N95 masks, prevent gouging

    The Indian government has ordered companies involved in the supply of N95 face masks to keep the cost of their products down. Officials issued the notice in response to reports of N95 face mask “hoarding, black-marketing and differential higher pricing.”   N95 face masks are classed as an essential commodity under an action the India government took in mid-March. The legislation makes hoarding and black-marketing a punishable offense. Officials have also directed regio...
  • Regulatory NewsRegulatory News

    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 ...
  • ReconRecon

    Recon: Sanofi to sell $13B stake in Regeneron; Merck to buy vaccine maker Themis Bioscience

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Regeneron to buy back $5 billion stake held by Sanofi ( Reuters ) ( Financial Times ) Merck to buy Austrian vaccine maker as it jumps into COVID-19 race ( Reuters ) ( STAT ) FDA shuffles longtime division head, Janet Woodcock, to focus exclusively on Covid-19 vaccine project ( STAT ) Evofem's gel first non-hormonal contraceptive to get approval in over 30 year...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA warns Seattle-based company for marketing COVID-19 vaccine

    The US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) on Thursday warned Seattle-based firm North Coast Biologics for marketing an unapproved vaccine for SARS-CoV-2, the virus that causes COVID-19, on Facebook and LinkedIn in March and April.   The warning letter comes nearly a month after Washington Attorney General Bob Ferguson sent a cease and desist letter to North Coast Biologics President Johnny Stine ordering him to “immediately stop mak...
  • ReconRecon

    Recon: FDA approves Sunovion Parkinson’s drug; Oxford-AZ vaccine moving to Phase 2/3 trials

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A quarter of Americans are hesitant about a coronavirus vaccine - Reuters/Ipsos poll ( Reuters ) Drug touted by Trump as COVID-19 treatment tied to increased risk of death: study ( Reuters ) ( Washington Post ) ( STAT ) ( The Lancet ) Prominent Scientists Denounce End to Coronavirus Grant ( NYTimes ) ( Science ) 'This is a bad practice': Doctors question FDA p...
  • Feature ArticlesFeature Articles

    A guide to good vendor management

    This article addresses best practices for regulatory affairs departments in their work with vendors. The author provides an overview of the vendor-contract giver relationship, then discusses finding an appropriate vendor, due diligence in selecting a vendor, vendor-related risk management, contract management, performance evaluation, maintaining the vendor-contract giver relationship, and the importance of follow-up meetings, audits, and reviews.   Introduction   A...
  • Regulatory NewsRegulatory News

    FDA issues guidance on PMA, HDE supplements amid COVID-19

    The US Food and Drug Administration (FDA) on Thursday issued an immediately effective guidance allowing medical device makers to make “limited modifications” to their devices without submitting a premarket approval (PMA) or humanitarian device exemption (HDE) supplement or a 30-day notice during the coronavirus disease (COVID-19) public health emergency.   FDA says the policy is meant to give device makers additional flexibility to address supply chain issues stemming ...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...