FDA Provides New Draft Guidance on Premarket Submissions for Device Software Functions
The following quote is attributed to Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health “As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices. The FDA recognizes this evolving [...]
EMA: Generating high-quality evidence from registry-based studies
EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on the planning and conduct of registry-based studies. A patient registry is an organised system that collects uniform data over time on patients who are diagnosed with a particular disease or condition, or who receive particular medicines. A registry-based study is [...]
FDA Revises Hospital and Health System Compounding Guidance to Help Preserve Patient Access to Compounded Drugs
Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. The FDA is continuing our efforts to help preserve access to compounded drugs for patients who have a medical need for them. We understand that compounded drugs can serve an important role for patients in hospitals [...]
FDA Provides Guidance on Measuring Patient-Reported Outcomes in Cancer Clinical Trials
The following quote is attributed to Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research “Patients would like to better understand symptoms they may experience and how a cancer therapy can affect their quality of [...]
FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain
The following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA's Center for Drug Evaluation and Research “Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products [...]
FDA Announces Draft Guidances to Help Increase Transparency, Assist Reporting and Timely Completion for Certain Medical Device Studies after FDA Approval or Clearance
The following quote is attributed to William Maisel, M.D., chief medical officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health: “Today, the FDA issued two draft guidance documents regarding the continuous surveillance of certain FDA approved and cleared devices. When final, these guidance documents will [...]
FDA Issues Draft Guidance on Early Clinical Studies for Certain Medical Devices to Improve Glycemic Control for Type 2 Diabetes
The following quote is attributed to Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health “As part of our commitment to help accelerate the development of innovative medical devices to improve patient care, the draft guidance issued today provides the FDA’s initial thinking on feasibility and early feasibility clinical studies for [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects – Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects – Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Pharmacovigilance Specialist based in Barcelona
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
Pharmacovigilance Specialist
Job Title Pharmacovigilance Specialist Job Summary Under the supervision of the Head of Pharmacovigilance, the position is responsible for supporting the Viglya activities in the following activities and roles. Primary Duties and Responsibilities Deputy EU QPPV for assigned projects. Local (deputy) QPPV for assigned projects - Spain. Project Lead for assigned projects. Maintain Safety Management [...]
FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19. “The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline [...]
EMA: Detailed guidance on ICSRs in the context of COVID-19
This detailed guidance document provides recommendations relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection, taking into account the Notice to stakeholders published by the European Commission and the guidance regarding COVID-19 related terms published by the MedDRA MSSO. [...]
EMA: Update to guidance on regulatory expectations in the context of COVID-19 pandemic
The European Commission, EMA and the national competent authorities have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union. Current national and international safety measures and travel restrictions affect or prevent the conduct of on-site inspections related [...]
EMA: Guidance on regulatory requirements in the context of the COVID-19 pandemic
The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients. The current pandemic is a global public health emergency causing major disruptions that impact citizens, [...]