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  • Regulatory NewsRegulatory News

    EMA offers new Q&A on data monitoring committees

    The European Medicines Agency (EMA) on Thursday released a new guideline offering nine questions and answers on issues related to the role of data monitoring committees (DMCs) in the conduct and management of clinical trials.   EMA explains that the recommendations of DMCs are not binding for trial sponsors, but that sponsors should justify and document and instances where such recommendations are not followed.   “The ultimate responsibility for a clinical trial re...
  • RoundupsRoundups

    Euro Roundup: MHRA to join Project Orbis

    The UK is set to join the US Food and Drug Administration’s (FDA) Project Orbis at the start of next year, Health Secretary Matt Hancock said during a speech on how the UK will approach the licensing of medicines after it leaves the European Union.   FDA set up Project Orbis to facilitate concurrent submission and review of cancer drugs among a pool of international regulators. The US agency worked with its peers in Australia and Canada to review Eisai’s Lenvima in com...
  • Regulatory NewsRegulatory News

    FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs

    The US Food and Drug Administration (FDA) has updated its Frequently Asked Questions on the development and performance of diagnostics for SARS-CoV-2, which includes the agency’s plan to decline to review emergency use authorization (EUA) requests for laboratory developed tests (LDTs).   That decision follows an announcement from the US Department of Health and Human Services that LDTs would not be required to undergo premarket review.   FDA will continue to pr...
  • Regulatory NewsRegulatory News

    Volunteers sought for CDRH cloud submission pilot

    Medical device firms can now apply to participate in a pilot US Food and Drug Administration (FDA) program for electronic delivery of medical device premarket submissions.   The pilot program, said FDA, provides a “voluntary alternate method” for developers to file premarket submissions to the Center for Devices and Radiological Health (CDRH) during the COVID-19 public health emergency. The pilot is intended to test the use of the Box cloud file sharing service, and to...
  • ReconRecon

    Recon: Moderna to seek EU rolling review for COVID-19 vaccine; Regeneron requests EUA for COVID-19 antibodies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna Vows to Not Enforce Covid-19 Vaccine Patents During Pandemic ( WSJ ) Regeneron Asks FDA for Emergency Approval for Drug That Trump Claimed Cured Him ( NYTimes ) ( Bloomberg ) ( Endpoints ) ( Reuters ) Trump says ‘no president’s ever pushed’ the FDA like him, vaccine coming ‘very shortly’ ( CNBC ) Regeneron antibodies in demand after Trump treatment, do...
  • Regulatory NewsRegulatory News

    FDA warns Battelle over EUA conditions for N95 decontamination system

    The US Food and Drug Administration (FDA) on Wednesday warned Battelle Memorial Institute for failing to comply with some of the conditions of its emergency use authorization (EUA) for its decontamination system for N95 respirators.   The warning letter is the first FDA has issued concerning a product being used under an EUA during the COVID-19 pandemic.   In March, Battelle became the first organization to receive an EUA for a decontamination system for N95 respir...
  • Regulatory NewsRegulatory News

    EMA moves to IRIS for scientific advice questions

    The European Medicines Agency (EMA) is transitioning to an online platform for drug developers to use when requesting scientific advice. The change will become effective on 19 October for developers of both human and veterinary medicinal products.   The regulatory and scientific information management platform, known as IRIS , “aims to make the handling of product-related regulatory procedures more efficient and user-friendly and to ensure better data quality through ...
  • RoundupsRoundups

    FDA Approvals Roundup: Alkindi, Haegarda, Kalydeco

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Alkindi approved as replacement therapy in children with adrenocortical insufficiency Eton Pharmaceuticals’ Alkindi Sprinkle (hydrocortisone oral granules) has been approved as a replacement therapy for adrenocortical insufficiency (AI) in children younger than 17 years. It is the first FDA-approved granular, lower-dose hydrocortisone formulati...
  • Feature ArticlesFeature Articles

    A regulatory anomaly: The NDA for water

    This is the story of a Code of Federal Regulations monograph for eyewash and a second regulation, which required a new drug application (NDA) for any drug sterilized by gamma irradiation. Both of these regulations did not take into consideration that water is a drug. Therefore, eyewash sterilized by gamma irradiation required an NDA. It took almost 14 years to eliminate the requirement of an NDA for eyewash sterilized by gamma. During this period, the company filed and rec...
  • Regulatory NewsRegulatory News

    FDA: Include premenopausal women in breast cancer trials

    Premenopausal women should be considered for inclusion in breast cancer clinical trials, according to new draft guidance from the US Food and Drug Administration (FDA). “Menopausal status should not be the basis of exclusion from any breast cancer clinical trial,” says the draft guidance, which was made available for a 60-day consultation period on 7 October.   The draft guidance puts forward recommendations to help move clinical breast cancer research away from the hi...
  • ReconRecon

    Recon: Eli Lilly seeks EUA for COVID antibody drug; BMS reports positive results for Opdivo plus chemo in NSCLC

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Says FDA Pulled ‘Political Hit Job’ With Vaccine Rules ( Bloomberg ) FDA Will Force Vaccine-Safety Disclosures If Makers Don’t ( Bloomberg ) Eli Lilly Asks FDA to Authorize Covid-19 Antibody Drug ( WSJ ) ( STAT ) ( Reuters ) FDA Redactions Upheld in FOIA Suit for Drug Approval Documents ( Bloomberg ) Bristol Myers' Opdivo succeeds in late-stage lung can...
  • Regulatory NewsRegulatory News

    FDA issues COVID-19 vaccine EUA guidance after clash with White House

    Amid reports that the White House had blocked stricter guidance from the US Food and Drug Administration (FDA) on emergency use authorizations (EUAs) for COVID-19 vaccines, the agency on Tuesday issued guidance hours after disclosing some of its advice to vaccine makers in briefing documents for an upcoming advisory committee meeting.   Last month, agency officials, including FDA Commissioner Stephen Hahn and Center for Biologics Evaluation and Research (CBER) Director...