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  • 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...
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    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...
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    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...
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    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...
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    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...
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    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 ...
  • ReconRecon

    Recon: FDA expands use of remdesivir for COVID-19; Nestle to buy Aimmune for $2B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA head says he is willing to fast-track Covid-19 vaccine ( FT ) ( Reuters ) ( The Hill ) FDA expands emergency use of Gilead's remdesivir in hospitalized COVID-19 patients ( Reuters ) ( FDA ) GSK, partner Vir join race to find COVID-19 antibody treatment ( Reuters ) ( STAT ) US scraps Philips ventilator order in 2020 earnings blow ( Reuters ) US government’...
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    FDA issues 36 new and revised product-specific guidances

    The US Food and Drug Administration (FDA) on Friday released its latest batch of product-specific guidances, posting 19 new and 17 revised draft guidances, bringing the total number of product-specific guidances issued by the agency to 1,938.   The guidances , which FDA posts quarterly, are intended to promote generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug...
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    FDA explains transfer of ownership policy for generics

    The US Food and Drug Administration (FDA) has issued a new manual of policies and procedures (MAPP) for transferring ownership of drug applications, including those due to corporate mergers and acquisitions.   The new MAPP outlines how Orange Book staff in the Office of Generic Drugs will process requests to transfer ownership of a drug application and explains the responsibilities of the current owner of the drug application as well as the new owner.   To transf...
  • ReconRecon

    Recon: New FDA communications chief out after plasma debacle; WHO looks to win over more wealthy countries to COVAX facility

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump pledges a Covid-19 vaccine by end of 2020 — without acknowledging the scientific uncertainty ( STAT ) ( Endpoints ) Two PR Experts at FDA Have Been Ousted After Blood Plasma Fiasco ( NYTimes ) Employers are planning how to blunt the cost of gene therapies, pricey new specialty drugs ( STAT ) Trump administration to purchase 150 million Abbott COVID-19 te...
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    October, no surprise: COVID-19 vax AdComm booked for the 22nd

    The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee plans to meet on 22 October to discuss matters related to authorization and licensure of vaccines for COVID-19. No application will be on the docket at that meeting.   The announcement via the Federal Register and the FDA’s Twitter account comes a day after the head of the key US vaccine research accelerator Operation Warp Speed (OWS) signaled that a COVID-19 vaccine m...