• Regulatory NewsRegulatory News

    FDA seeks new members for Patient Engagement Collaborative

    The US Food and Drug Administration is seeking eight new members for its Patient Engagement Collaborative (PEC), a group charged with gaining meaningful patient input into medical product development and regulatory decision making.   The 16-member panel includes patients, caregivers, and advocates who serve for 2 to 3 years. The panel is a joint effort between FDA and the Clinical Trials Transformation Initiative . Panel members are expected to participate in two to f...
  • Regulatory NewsRegulatory News

    Patient Engagement in Device Trials: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Monday released new draft guidance explaining how sponsors can improve the design and conduct of medical device clinical investigations by using patient experience, perspectives and other relevant information. The 10-page draft mainly addresses four questions: What approaches might sponsors use to engage patient advisors (defined by FDA as those who have dealt with or are dealing with a particular condition but are not inv...
  • Regulatory NewsRegulatory News

    Patient Engagement in Device Trials: FDA Meeting Discusses Challenges and Opportunities

    Last week, the US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time to look at ways to increase patient engagement in clinical trials for medical devices. Owen Faris, clinical trials director at the Center for Devices and Radiological Health (CDRH), said the opportunity to engage with patients goes beyond using patient reported outcomes (PROs) and patient preference information (PPI) in regulatory decision-making. A...
  • Regulatory NewsRegulatory News

    FDA Holds First Patient Engagement Advisory Committee Meeting

    The US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time on Wednesday and Thursday to give the agency input from  patients on clinical trials for medical devices. The meeting focused on a number of key issues related to clinical trials, with the goal of increasing patient input on trial design; patient recruitment, enrollment and retention; and communicating results back to patients. Patient Engagement at FDA FDA ...
  • Regulatory NewsRegulatory News

    EMA Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias

    Following an inquiry into the perception of bias in early interactions between the biopharma industry and the European Medicines Agency (EMA), EMA executive director Guido Rasi tried to assure the EU ombudsman that the risk of bias is manageable. "While we acknowledge the need to avoid and manage any risk of bias, experience over the years shows that such risk can be managed by having in place the necessary safeguards and I can assure you that the Agency guarantees...
  • Regulatory NewsRegulatory News

    Industry Supports FDA Proposal to Create New Office of Patient Affairs

    Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs. The idea for the new Office of Patient Affairs (OPA), proposed in March , is part of the agency’s efforts to offer "a single, central entry point to the Agency for the patient community," as well as "triage and navigation services for inbound inquir...
  • Regulatory NewsRegulatory News

    FDA Considers Creating New 'Office of Patient Affairs'

    As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency. The move to create the office would be part of the agency’s efforts to offer “a single, central entry point to the Agency for the patient community,” as well as “triage and navigation services for inbound inqu...
  • 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...
  • Feature ArticlesFeature Articles

    Pharmaceutical Marketing via Social Media

    This article discusses the ongoing effort by the pharmaceutical industry to use social media as a marketing tool. It presents benefits and limitations of using this form of media and describes recent progress in public communication. Pharmaceutical marketing is the practice of promoting and selling medicines to patients through different media. The broad scope of this definition encompasses all means for the purpose of marketing and sales adopted by a company. A drug c...
  • 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’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...
  • FDA Report: Agency Moving to Engage Globally to Meet Realities of Supply Chain

    The US Food and Drug Administration (FDA) Commissioner Margaret Hamburg released a new report that aims to show how the regulatory agency is revamping itself from a domestic agency to one with a "global public health focus". "As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world," said Hamburg in a statement. FDA's Global Engageme...