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  • Regulatory NewsRegulatory News

    Generic drugmakers get guidance on tentative approvals, CRLs

    Generic drug makers received a final and a draft guidance from the US Food and Drug Administration (FDA) on 28 September that address components of the submission process for an abbreviated new drug application (ANDA).   The draft guidance for generic drugmakers seeks to address problems created when a sponsor fails to respond to an ANDA complete response letter (CRL) within the timeframe stipulated by federal regulations.   The three choices an ANDA sponsor has on...
  • Regulatory NewsRegulatory News

    FDA finalizes blood glucose monitor guidances

    The US Food and Drug Administration (FDA) on Monday finalized guidance providing recommendations for device makers looking to submit 510(k)s for prescription point-of-care and over-the-counter blood glucose monitoring systems (BGMSs), two years after the agency went back to the drawing board to address concerns about its previous guidance.   FDA first issued final guidance on point-of-care and over-the-counter BGMSs in October 2016. In November 2018, in response to ind...
  • Regulatory NewsRegulatory News

    Breast implant label guidance finalized by FDA

    The US Food and Drug Administration (FDA) issued final guidance on improving patient information regarding breast implants on 28 September. The final guidance largely echoes draft labeling guidance issued in October 2019, with some clarifications surrounding the relationship between implants and systemic disease, language to improve the readability of the patient device card, and information on specific registries to track real-world data on breast implants.   FDA reco...
  • ReconRecon

    Recon: FDA puts Inovio COVID-19 vaccine trial on hold; Pfizer urged to gather more safety data before seeking vaccine EUA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Inovio Covid-19 Vaccine Trial Placed on Hold After FDA Questions ( WSJ ) ( Reuters ) New document reveals scope and structure of OWS, underscores vast military involvement ( STAT ) The 8 most important leaders of Operation Warp Speed ( STAT ) Trump’s drug card plan sows confusion – even within administration ( Politico ) FDA coffers are tapped for a down paym...
  • Feature ArticlesFeature Articles

    MDR, IVDR, and compliance: A guide for distributors

    Distributors must prepare for new incoming requirements under EU medical device and in vitro diagnostic device regulations. The importance of establishing an effective quality management system, drafting comprehensive contractual agreements and, if required, engaging notified bodies, has created much uncertainty for distributors. To fulfil these new requirements and maintain device supply chains, it is essential for distributors to act early, ensure sufficient in-house com...
  • Regulatory NewsRegulatory News

    HHS opens pathway to importing Canadian drugs

    The US Department of Health and Human Services (HHS) has issued a final rule that clears a path for importation of some Canadian drugs into the US. The measure follows a 24 July 2020 executive order issued by President Donald Trump that directed the HHS secretary to take action to expand access to lower-cost imported drugs. In a 24 September press release, the US Food and Drug Administration (FDA) said that the final rule would help affordability of drugs for US patient...
  • Regulatory NewsRegulatory News

    Experts call on Hahn to shield FDA from political influence

    More than 30 leading experts and academics in regulatory science and medicine have signed an open letter calling on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to protect the agency from political interference.   The letter comes days after President Donald Trump, who has repeatedly claimed that a coronavirus disease (COVID-19) vaccine could be authorized before the November election and accused FDA staff of being part of “the deep state,” said ...
  • Regulatory NewsRegulatory News

    CONSORT-AI sets standards for reporting on artificial intelligence in trials

    A new consensus statement, dubbed the CONSORT-AI extension, lays out the rules of the road for clinical trial reports on interventions involving artificial intelligence (AI).   The statement, which was published in Nature Medicine and written by an international working group, includes 14 new items for researchers to routinely include in their manuscripts when reporting on AI interventions.   The statement calls on researchers who report on trials that include AI...
  • ReconRecon

    Recon: AstraZeneca gets partial liability protection in EU vaccine deal; Novavax COVID vaccine enters Phase 3

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How Trump is undermining his own vaccine race ( Politico ) Trump signs US healthcare executive orders that may have little impact ( Reuters ) ( WSJ ) Trump promises drug discount cards as a $200 pre-election gift ( NYTimes ) ( STAT ) ( Reuters ) ( Politico ) Cuomo says New York to review any COVID-19 vaccine authorized by federal government ( Reuters ) ( NPR )...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the  United Kingdom  and  Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan  and Australia.   Convalescent plasma may be used in the US to treat hospitalized patients under an emergency use authorization (EUA) or an investigational new drug application (IND). “Adequate and well-controlled randomized trials remain ne...
  • Regulatory NewsRegulatory News

    EMA addresses use of registry-based studies

    The European Medicines Agency (EMA) has issued a new guideline on registry-based studies, giving detailed advice for use of patient registries in both the pre- and post-authorization phases for medicinal products.    After committee approval and a consultation period with the EU Regulatory Network, the guideline has been released for public consultation, with comments due before the end of 2020.   The guideline’s focus is on the use of patient registries for studie...
  • Regulatory NewsRegulatory News

    FDA finalizes ASCA pilot guidance as it gears up for launch

    The US Food and Drug Administration (FDA) on Thursday issued three final guidances on its Accreditation Scheme for Conformity Assessment (ASCA) pilot program.   The program, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV), is meant to increase “consistency, predictability and efficiency” during the premarket review of medical devices by creating a scheme for accrediting third party testing laboratories to eligible con...