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  • Regulatory NewsRegulatory News

    Device Industry, Notified Bodies to Offer Feedback to MDCG at MDR Meetings Next Month

    The European Commission’s Medical Device Coordination Group (MDCG) on 11, 12 March will hold a series of meetings, partly to hear additional feedback from industry and notified bodies on their preparedness for the application of the Medical Devices Regulation (MDR) on 26 May. Following a previous meeting between industry and the MDCG on 30 September , this next set will focus on MDR implementing acts, updates on MDCG subgroups, as well as a progress report on the proce...
  • Regulatory NewsRegulatory News

    CHMP Recommends One New Drug, Begins Review of Indian CRO

    At its meeting earlier this week the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended one new and one generic medicine for authorization and launched a review of medicines supported by an Indian contract research organization (CRO) citing data integrity concerns.   Specifically, CHMP recommended the authorization of Shionogi’s Fetroja (cefiderocol) to treat Gram-negative bacterial infections and Accord Healthcare’s gen...
  • Regulatory NewsRegulatory News

    FDA Guidance Snapshots: Launch of a New Pilot

    The US Food and Drug Administration (FDA) on Friday unveiled a new pilot program to release “Guidance Snapshots” for a subset of cross-cutting guidance documents on topics related to modernizing drug clinical trials and accelerating drug development. The agency has so far released three of these snapshots, which offer highlights from guidance documents using visuals and plain language. Two of the snapshots are related to guidances providing recommendations to drugmakers...
  • ReconRecon

    Recon: FDA Approves Biohaven Migraine Drug; WHO Says Global Risk of Coronavirus is ‘Very High’

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biohaven drug wins US FDA approval for use in relieving migraine headaches ( Reuters ) ( Endpoints ) US mulls using sweeping powers to ramp up production of coronavirus protective gear ( Reuters ) Mixed messages, test delays hamper US coronavirus response ( Reuters ) ( Politico ) US workers without protective gear assisted coronavirus evacuees, HHS whistleblow...
  • Regulatory NewsRegulatory News

    Why FDA Can’t Disclose the First Coronavirus-related Drug Shortage

    Around 10 pm ET last night, the US Food and Drug Administration (FDA) said that it is aware of a drug shortage related to an active pharmaceutical ingredient (API) manufacturer affected by the coronavirus, but the agency stopped short of revealing what drug it is.   “The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug. It is important to note that there are other alternatives that can be used by patients. We are wo...
  • Regulatory NewsRegulatory News

    Reliance on Drug Imports, Coronavirus Supply Chain Concerns Raised in House Hearing

    The prospect of pharmaceutical supply disruptions caused by the ongoing coronavirus (COVID-19) outbreak, as well as concerns with the US Food and Drug Administration’s (FDA) oversight of foreign drug manufacturing, were raised by representatives during a House Appropriations subcommittee hearing Thursday.   Suzanne Murrin, deputy inspector general for evaluation and inspections at the Department of Health and Human Services Office of Inspector General, fielded question...
  • Regulatory NewsRegulatory News

    NESTcc Unveils Frameworks on Quality Data, Methodologies for Device RWE

    The National Evaluation System for health Technology Coordinating Center (NESTcc), a public-private partnership, late Wednesday released two frameworks related to data quality and research methods as part of its work to enable and support the use of real-world evidence (RWE) to better understand certain medical devices. The data quality framework is based mostly on electronic health record (EHR) data in the clinical care setting, while the methods framework applies thos...
  • ReconRecon

    Recon: Trump Names Pence to Head Coronavirus Response; FDA Panel Narrowly Backs Lilly’s Cyramza Combo in NSCLC

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US isn’t ready to detect stealth coronavirus spread ( Politico ) CDC Appears To Have Fixed Issue Delaying Coronavirus Testing In US ( NPR ) Pence Will Control All Coronavirus Messaging From Health Officials ( NYTimes ) ( Reuters ) ( Politico ) CDC flags possibility of community spread of coronavirus ( Reuters ) ( NYTimes ) ( CDC ) Coronavirus Patient in Calif...
  • Feature ArticlesFeature Articles

    Regulatory and Legal Roles in Promotional Review Committee Meetings: Is there really a difference?

    This article provides perspectives on how legal and regulatory personnel and others view their roles when participating in promotional and other types of material reviews. The author defines and separates the roles and provides the results of an informal survey regarding what people in the industry think about the nature of the two roles in reference to promotional reviews. She concludes by suggesting that moving the company forward in a compliant way should be everyone’s ...
  • RoundupsRoundups

    EU Regulatory Roundup: Swissmedic Authorizes First Drug Under International Work Sharing Initiative

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Swissmedic Authorizes First Drug Under International Work Sharing Initiative   The Swiss Agency for Therapeutic Products (Swissmedic) has approved a drug under its international work sharing initiative for the first time. Swissmedic authorized Roche’s antiviral Xofluza for sale after working with its peers in Australia and Canada.   Health Canada and Australia’s...
  • Regulatory NewsRegulatory News

    FDA Aware of Some Shortages of Personal Protective Equipment at Hospitals

    The US Food and Drug Administration (FDA) told Focus on Thursday that it has heard of spot shortages of some medical devices, including personal protective equipment (PPE) used by hospitals to guard against the coronavirus (COVID-19).    “However, FDA is currently not aware of specific widespread shortages of medical devices, but we are aware of reports from CDC [Centers for Disease Control and Prevention] and other partners of increased ordering of a range of human ...
  • Regulatory NewsRegulatory News

    OIG Finds Most Drugs can be Traced Through Supply Chain Thanks to DSCSA

    The Department of Health and Human Services’ Office of Inspector General (OIG) on Wednesday released a report finding it could trace more than 80% of the drugs it attempted to trace through the supply chain. Of 44 selected drugs to be traced through the supply chain using drug product tracing information that the Drug Supply Chain Security Act (DSCSA) requires, OIG found all but seven could be traced back to the manufacturers. Of the seven that could not be traced,...