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  • ReconRecon

    Recon: China vaccinates 100K for COVID; EUA for Roche COVID-flu combo test

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Genentech scores sixth FDA approval in lung cancer with Gavreto ( Pharmafile ) US FDA Personnel Costs Drop: Is the Next Generation Taking Over? ( Pink Sheet ) Gottlieb: Staged Access To Coronavirus Vaccine Possible Through EUA ( Pink Sheet ) Why Saving The Economy Or Tackling The Pandemic Is A False Dilemma ( Forbes ) Here’s how Trump could bigfoot the FDA an...
  • ReconRecon

    Recon: Russian COVID vaccine shows antibody response in early trials; AbbVie to develop, sell I-Mab cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Covid-19 Vaccine Race Turns Deep Freezers Into a Hot Commodity ( WSJ ) Leader of US vaccine push says he‘ll quit if politics trumps science ( Science ) ( NPR ) US will not 'cut corners' in developing coronavirus vaccine, Pence says ( Reuters ) White House: no one pressuring FDA to approve coronavirus vaccine ( Reuters ) Moderna slows vaccine trial enrollment ...
  • Regulatory NewsRegulatory News

    COVID convalescent plasma guidance gets EUA updates

    Guidance for industry on the use of convalescent plasma for patients with COVID-19 has been updated to reflect the 23 August Emergency Use Authorization (EUA) for the investigational product. The guidance clarifies which pathways are available for use of COVID-19 convalescent plasma and announces a period of enforcement discretion for transition to collection requirements outlined in the EUA.   Updates to the US Food and Drug Administration (FDA) guidance account for...
  • ReconRecon

    Recon: CDC tells states to prep for COVID vaccine by November; 76 wealthy countries join COVAX plan

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Admin Asks States to Be Ready for Vaccine by November ( WSJ ) ( Reuters ) ( NYTimes ) ( FT ) Pfizer targets end of next month for COVID-19 vaccine update ( Reuters ) Unlikely that a COVID-19 vaccine will be ready in October, but not impossible, Fauci says ( Reuters ) Merck CEO sees human trials for COVID-19 vaccine candidate 'fairly soon' ( Reuters ) Pr...
  • RoundupsRoundups

    FDA Roundup: Sogroya, Onureg, Winlevi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Sogroya okayed as weekly therapy for adult growth hormone deficiency Novo Nordisk’s Sogroya (somapacitan-beco injection) has been approved as the first once-weekly, human growth hormone (hGH) therapy for adults with growth hormone deficiency.   Until now, the only treatment option for patients with the disorder has been a daily formulation of t...
  • ReconRecon

    Recon: FDA communications shakeup continues; EU considers joining WHO vaccine purchasing scheme

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA to bring outside experts to review COVID-19 vaccines ( Reuters ) FDA shake-up continues as another comms official removed from top role ( Politico ) Convalescent plasma not recommended to treat COVID-19, government panel says ( NBC ) ( FT ) US says it won’t join WHO-linked effort to develop, distribute coronavirus vaccine ( Washington Post ) Trump says he...
  • Regulatory NewsRegulatory News

    N-Nitrosamine impurities: FDA issues detection, prevention guidance

    An immediately effective guidance from the US Food and Drug Administration (FDA) details steps to be taken to detect and prevent the introduction of potentially carcinogenic nitrosamine impurities into finished drug products and active pharmaceutical ingredients.   “The recent unexpected finding of nitrosamine impurities, many of which are probable or possible human carcinogens, in drugs such as angiotensin II receptor blockers, ranitidine, nizatidine, metformin, rifam...
  • Regulatory NewsRegulatory News

    FDA warns Mylan, Acella Pharmaceuticals over GMP violations

    The US Food and Drug Administration (FDA) last month warned Mylan Laboratories and Acella Pharmaceuticals over good manufacturing practice (GMP) violations.   Mylan Laboratories   FDA’s warning letter to Mylan comes after the agency inspected the company’s facility in the Sangareddy District of Telangana, India over the course of a week last February.   The warning letter, which cites the company for issues related to its cleaning procedures and handling of r...
  • ReconRecon

    Recon: AstraZeneca begins US Phase III COVID vaccine study; FDA approves Medtronic’s new automated insulin delivery system

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Early vaccine approval is biggest test yet for FDA chief ( FT ) As fears of a politically-motivated vaccine EUA grow, Eric Topol delivers an ultimatum to commissioner Hahn: Stand up or resign ( Endpoints ) ( Medscape ) AstraZeneca's COVID-19 vaccine candidate begins late-stage US study ( Reuters ) Congressional committee to subpoena AbbVie in drug pricing inve...
  • Regulatory NewsRegulatory News

    Combination products: FDA releases PDUFA VI program report

    A new independent report on the US Food and Drug Administration’s (FDA) review practices for combination products under the Prescription Drug User Fee Act (PDUFA VI) gives the agency generally positive marks but finds room for refinements in communication and technology to improve the pre-submission and review process.   The report , commissioned by FDA as part of its PDUFA VI commitments, was conducted by Eastern Research Group and looked at FDA staff and sponsor e...
  • Regulatory NewsRegulatory News

    FDA updates deferral guidance for blood and plasma donation

    An update to guidance for industry on reducing the risk of transmission of Creutzfeldt-Jacob disease (CJD) through blood and blood components clarifies terminology and recommendations for patients who have received cadaveric pituitary human growth hormone. Some previous travel-based deferrals have also been revised or eliminated.   The revised guidance from the US Food and Drug Administration (FDA) addresses screening for variant CJD (vCJD) as well as other transmissib...
  • Regulatory NewsRegulatory News

    FDA releases draft guidance on PROs for device manufacturers

    Device manufacturers have new draft guidance from the US Food and Drug Administration (FDA) for the selection of patient-reported outcome instruments in clinical evaluation of their products. The guidance details such topics as modification or adaptation of existing instruments, and the possibility of nesting patient-reported outcome instruments within real-world data sources.   The new draft was jointly issued by the Center for Devices and Radiological Health and the ...