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  • Regulatory NewsRegulatory News

    FDA’s first patient-focused drug development guidance now final

    Final guidance for drugmakers on gathering comprehensive and representative input from patients is now available from the US Food and Drug Administration (FDA).   The document is the first in a series of four that will outline patient-focused drug development (PFDD) guidance “to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information fr...
  • Regulatory NewsRegulatory News

    Patient-Focused Drug Development: New FDA Draft Guidance Delves Into What’s Important

    The US Food and Drug Administration (FDA) on Monday published the second in a series of four guidance documents on patient-focused drug development, with this latest draft helping sponsors identify what is most important to patients with respect to their experience with disease burden and treatment. In determining what’s important, FDA recommends that sponsors use qualitative research methods, which can generate in-depth thoughts from patients in their own words through...
  • Regulatory NewsRegulatory News

    UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges. “Users of Accu-Chek Insight insulin pump system with NovoRapid PumpCart cartridges, can check for any leaked insulin in the cartridge compartment...
  • 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

    FDA Offers New Draft Guidance on How Device Manufacturers Can Share Data With Patients

    As patients increasingly play a more active role in their own healthcare, the US Food and Drug Administration (FDA) on Thursday issued new draft guidance to clarify that medical device manufacturers may share patient-specific information recorded, stored, processed, retrieved and/or derived from a device that helps to treat or diagnose that patient. The draft guidance outlines considerations for the form in which this device data – which can include usage statistics (pul...
  • Regulatory NewsRegulatory News

    Patient-Focused Drug Development Tracker

    Since the passage of the  Food and Drug Administration Safety and Innovation Act (FDASIA)  in 2012, the US Food and Drug Administration (FDA) has been publicly meeting with patients who suffer from debilitating conditions without adequate treatment options in the hopes of better understanding their wants and needs in the drug development process. Those meetings have raised novel questions for regulators, who for the first time are asking patients and patient groups to ex...
  • Regulatory NewsRegulatory News

    BIO Calls for Increased Emphasis on Patient Perspectives by Biopharma, FDA

    Biopharmaceutical companies should seek out and incorporate the perspective of patients earlier on in the drug development process, a new white paper from the Biotechnology Industry Organization (BIO) argues. Background The call comes in the midst of a sustained shift by both companies and regulators to incorporate the views of patients into the regulatory process. Starting in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA has begu...
  • Regulatory NewsRegulatory News

    Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices

    Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way. Background On 24 April 2015, Sens. Richard Burr (R-NC), Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced the Advancing Breakthrough Devices for Patients Act ( ABDP Act ) . As written, the law is heavily based on the "breakthrough therapies" section ( Section 902 ) of th...
  • Feature ArticlesFeature Articles

    China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval

    Local clinical data are essential as supporting evidence for new drug applications (NDAs) in China. This article reviews the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014. It provides insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China. Ch...
  • Regulatory NewsRegulatory News

    Does FDA Need New Authority to Regulate Complex Generic Drugs?

    New legislation introduced in the US House of Representatives seeks a government investigation into the US Food and Drug Administration's (FDA) review of complex generic pharmaceuticals to consider whether the agency is in need of new regulatory authority. Background The bill, the Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 , was introduced on 24 March 2015 by Rep. Michael Burgess (R-TX), a former physician and member of the House Energy a...
  • Regulatory NewsRegulatory News

    How can FDA be Improved? Patient Groups Offer Ideas

    More than a dozen patient groups and trade associations are offering their advice to the US Food and Drug Administration (FDA) on ways the agency can improve its regulatory and administrative processes to take into account the views and expertise of patients and their advocates. Background Since 2012, FDA has launched several initiatives meant to better take into account the views of patients. Some, like its patient-focused drug development initiative , have involv...
  • Regulatory NewsRegulatory News

    Is FDA Listening Enough to Patients? Agency Wants Feedback

    When Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, its patient-centered provisions were among the biggest changes set to impact the culture of the US Food and Drug Administration (FDA). Now, two years later and with major planning already underway regarding the future of FDA's patient-centered activities, agency regulators are reaching out to the public to ask what more they can do to improve their efforts. Backgr...