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  • Regulatory NewsRegulatory News

    FDA Explains Plans to Use Real-World Data in Medical Device Regulatory Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance clarifying how it plans to determine cases when real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the standards used to make those decisions. The 21-page draft document, which is open for comment for the next 90 days, also explains how the agency plans to evaluate real-world data to determine whether it may be sufficiently relevant a...
  • Regulatory NewsRegulatory News

    Researchers: Patient Reported Outcomes for Heart Failure Fail to Meet FDA Criteria

    A team of researchers say that no currently available patient-reported outcomes for heart failure meet the US Food and Drug Administration's (FDA) criteria for supporting product approval. In a recently published review in the Journal of the American College of Cardiologists , the researchers checked the patient-reported outcomes against nine criteria adapted from the 14 listed in FDA's 2009 guidance, Patient-Reported Outcome Measures: Use in Medical Product Developme...
  • Regulatory NewsRegulatory News

    EMA and FDA Begin Collaborations on Patient Engagement

    The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Wednesday began exchanging more information on the best practices of involving patients in the development, evaluation and post-authorization tracking of medicines. The EMA/FDA teleconference, also known by EMA as a "cluster," on patient engagement seeks to increase the exchange of information on engaging with and involving patients and their organizations within the regulators’ wor...
  • Regulatory NewsRegulatory News

    CDISC Unveils New Standard for Clinical Trial Registries

    • 09 May 2016
    The new standard from the Clinical Data Interchange Standards Consortium (CDISC) will help industry generate submissions for multiple, global clinical trial registries, particularly those from the World Health Organization (WHO), European Medicines Agency (EMA) and ClinicalTrials.gov from a single file. The standard, known as the Clinical Trial Registry (CTR) XML, is inspired by the International Committee of Medical Journal Editors (ICMJE), and is based upon the 2...
  • Feature ArticlesFeature Articles

    Advancing Regulatory Science: Research Success in a Public-Private Partnership

    This article discusses how a public-private partnership brought stakeholders together to advance regulatory science research in patient preference assessment. In May 2015, the Medical Device Innovation Consortium (MDIC) published a first-of-its-kind report, "A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology." 1 This "Framework" is not only a break-through publication in the...
  • Regulatory NewsRegulatory News

    FDA to Host Public Meeting on Psoriasis Patient Perspectives

    The 17 March 2016 public meeting at the US Food and Drug Administration (FDA) will allow for patients to offer their unique perspectives on the impact of psoriasis, including on daily life and treatment options. FDA says it’s interested in “patients’ perspectives for the types of psoriasis with primarily skin symptoms (such plaque psoriasis, nail psoriasis, guttate psoriasis, etc.), patient views on treatment approaches, and decision factors taken into account when selec...
  • Regulatory NewsRegulatory News

    FDA Warns of Medical Device Coating Separation Issues

    The separation of coatings on certain intravascular medical devices has the potential to cause serious injuries to patients, the US Food and Drug Administration (FDA) warned on Monday. FDA is trying to make health care providers aware that patients could be at risk if the hydrophilic and/or hydrophobic coatings separate (e.g., peel, flake, shed, delaminate, slough off) from devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheat...
  • Regulatory NewsRegulatory News

    Califf: Patient Preferences Too Often Overlooked in Medical Product Development, Approvals

    As patients play a more active role in which regulated products are used in their care, the US Food and Drug Administration (FDA) is working on several programs to ensure patient perspectives have an effect on which of those products are developed and approved, FDA commissioner nominee Robert Califf and other agency officials said in a JAMA Viewpoint published Thursday. FDA is now participating in a number of different drug and medical device initiatives that directly in...
  • Regulatory NewsRegulatory News

    FDA Releases Draft Guidance on Injectable Drug Dose Labeling

    Citing safety concerns, the US Food and Drug Administration (FDA) is updating its guidance to industry on how to properly label injectable drugs for their appropriate doses. The guidance also updates the agency's definition of single- and multiple-dose containers and retires the term "single-use," in favor of the term "single-patient-use," which the agency says will reduce confusion for some products. Single-Patient-Use The introduction of this new term, "single-patien...
  • Regulatory NewsRegulatory News

    EMA Sets Up Two-Year Pilot Program on Patient Registries

    The European Medicines Agency (EMA) has launched an initiative focused on existing patient registries, with the aim of seeing how they can be better used as a source of post-authorization data, and how they can help to establish new registries. Background EMA defines a registry as a system using observational methods over time to collect uniform data on a population defined by a particular disease, condition, or exposure. A disease registry includes patients bas...
  • Regulatory NewsRegulatory News

    FDA’s CDRH Unveils First-Ever Patient Engagement Advisory Committee

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Friday announced the establishment of the first-ever Patient Engagement Advisory Committee (PEAC) to ensure patient needs and experiences are included during the review of medical devices. The committee, which will be made up of nine voting members, one non-voting industry representative and one non-voting consumer representative, will bring together patients, patient a...
  • Regulatory NewsRegulatory News

    FDA to Focus on Autism, Psoriasis Under New Patient-Focused Program

    The US Food and Drug Administration (FDA) has released a pared-down list of diseases it plans to assess over the coming two years as part of its Patient-Focused Drug Development (PFDD) program—an integral part of the most recent authorization of the Prescription Drug User Fee Act (PDUFA). The PFDD was created in an attempt to bring patients into the regulatory process in a more systematic way. Instead of asking for patient feedback on a drug-by-drug basis, the PFDD asks ...