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  • Regulatory NewsRegulatory News

    Hahn insists FDA will stick to guidelines for COVID-19 vaccine decisions

    Speaking at the Financial Times ’ US Pharma and Biotech Summit on Tuesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said the agency will stick to the standards and criteria it has laid out to approve or authorize applications for vaccines to prevent coronavirus disease (COVID-19).   In recent weeks, Hahn has made numerous statements asserting that the agency will not approve or authorize a vaccine that does not meet the agency’s “rigorous expect...
  • Regulatory NewsRegulatory News

    HHS, to address insulin price crisis, issues RFP for reimportation

    The US Department of Health and Human Services (HHS) has issued a request for proposals for reimportation of insulin produced in the United States and exported for sale abroad.   The measure, said HHS, is meant to address the fact that “The rising price of insulin, and corresponding rationing of insulin, constitutes an emergency” within the US. The agency noted that insulin prices rose nearly six-fold between 2002 and 2016. One commonly prescribed insulin, said HHS, ha...
  • Regulatory NewsRegulatory News

    Study calls for proactive surveillance of device AEs

    The US Food and Drug Administration (FDA) relies mainly on direct reports and regulator-initiated surveillance to flag safety concerns around medical devices, a system that may delay detection of adverse events (AEs), according to a new analysis published in JAMA Internal Medicine . “These data highlight the importance of proactive identification of postmarketing device-related safety issues to provide health care professionals with more complete data regarding potenti...
  • Regulatory NewsRegulatory News

    Drug mutagenicity, proarrhythmic potential addressed in pair of FDA guidances

    The US Food and Drug Administration (FDA) has issued two new draft International Council on Harmonisation (ICH) guidelines for public consultation.   A question-and-answer (Q&A) guidance on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of medicines was published in draft form by FDA on 29 September; the guidance is currently in ICH Step 2b, awaiting consultation from the Council's participating countries. The draft guid...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA seeks feedback on device adverse events, UDIs

    Australia’s Therapeutic Goods Administration (TGA) is seeking feedback from the industry and consumers about proposed enhancements to medical device adverse event reporting, posing the same set of questions “through a different lens” to each group.   The consultation is split up into five proposals, which include making changes to the current adverse event reporting exemptions and strengthening the reporting requirements.   For each proposal, TGA provides an overvi...
  • ReconRecon

    Recon: Catalyst loses orphan approval suit against FDA; California adopts law to pursue its own generics

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Top FDA vaccine official says vaccine guidance may never be released ( Politico ) Catalyst loses lawsuit accusing the FDA of unfairly approving a rival rare disease drug ( STAT ) Trump admin begins shipping rapid coronavirus tests to states ( Politico ) ( Reuters ) Big Pharma Backs Joe Biden, But People Don't Think He'll Fix Drug Pricing ( Newsweek ) Drug ind...
  • 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

    Updated 29 September to add comment from CDRH official 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...
  • 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...