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  • 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

    FDA to Systematically Incorporate Patient Preferences into Device Approvals

    US medical device regulators at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) have unveiled a proposed framework for the collection and use of patient preference information (PPI) in medical device development. Background The new draft guidance document, Patient Preference Information –Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling , is closely related to CDRH's...
  • Regulatory NewsRegulatory News

    UPDATED: New to FDA's Advisory Committee Briefing Documents: Patient Testimony

    Patients and their advocates appear to be getting more prominent attention from the US Food and Drug Administration (FDA) if a recent release of documents in advance of an upcoming advisory committee meeting is any indication. This story has been updated to include additional information from FDA and to correct one inaccuracy: Patient testimonials have always been made available to advisory committee members in advance of meetings, even if they are not publicly po...
  • Regulatory NewsRegulatory News

    Bill Would Give Some Reformulated Drugs Extra Protection from Generics

    New legislation introduced in the US House of Representatives would give some pharmaceutical products an extra two years of marketing exclusivity if their sponsors are able to demonstrate that the redesigned or reformulated drugs improve adherence, decrease abuse or otherwise make the drug safer to take. Background The bill, the Promoting Access for Treatments Ideal in Enhancing New Therapies (PATIENT) Act of 2015 , was introduced in the House on 13 March 2015 by Rep...
  • 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...
  • Regulatory NewsRegulatory News

    FDA Seeks Patient Insight Into Autism, Depression and 14 Other Conditions

    The US Food and Drug Administration (FDA) has announced a second batch of meetings intended to facilitate the development of drugs for neglected conditions by taking into account the perspective of the patients suffering from the conditions. Background In recent years, some patient groups—and in particular groups representing patients suffering from serious diseases with few or no suitable treatments—have begun to express their concerns that FDA is too stringent when it...
  • Regulatory NewsRegulatory News

    After New Drugs Delayed by DEA, Legislators Seek Overhaul of Drug Scheduling Process

    For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA ) , the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs. Now new legislation wants to make the process by which DEA ...
  • Regulatory NewsRegulatory News

    FDA Wants Input on Patient-Developed DMD Guidance

    The US Food and Drug Administration (FDA) is calling for public comment on a new draft guidance document developed by patient advocates and intended to accelerate the development of therapies to treat Duchenne Muscular Dystrophy (DMD). Background In June 2014, Parent Project Muscular Dystrophy (PPMD) and other stakeholders submitted a draft guidance document to FDA which they said would "help accelerate development and review of potential therapies for DMD." The guid...
  • Regulatory NewsRegulatory News

    Following Criticism, FDA to Focus on Female Sexual Disorders at Upcoming Patient Meeting

    The US Food and Drug Administration (FDA) this week quietly announced that it soon plans to hold a meeting on female sexual dysfunction (FSD) as part of a larger effort to bring patients into the drug development process to fine-tune its benefit-risk assessment process. Background The meeting will be the 11th under FDA's Patient-Focused Drug Development process—an initiative created under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) to he...
  • Feature ArticlesFeature Articles

    Filling a Regulatory Void: Patient Advocates Submit Guidance for Duchenne Muscular Dystrophy

    Muscular dystrophy (MD)––a group of diseases that cause progressive muscle weakness due to defects in muscle proteins ––has a range of complex features that make treatments elusive. MD exists in many forms (Duchenne MD is the most common); animal models do not accurately reflect human disease; and it is difficult to define and measure the progression of this slow disease. Because MD can be life-threatening, new disease-modifying (serving to slow or halt progression) an...