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  • Regulatory NewsRegulatory News

    EMA Re-Elects Former MHRA Regulator to Lead Influential Management Board

    The European Medicines Agency (EMA) has announced the re-election of Sir Kent Woods as the chair of its influential 35-member Management Board, which sets regulatory policies for the agency. Woods, who served as chief executive at the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) between 2004 and 2013 , will now serve as the board's chair for a final three-year term, after which time term limits preclude him from running again. Woods said in ...
  • Regulatory NewsRegulatory News

    FDA Finalizes IRB Transfer Guidance With Minimal Changes

    • 22 May 2014
    The US Food and Drug Administration (FDA) has announced the release of a final document intended to instruct sponsors, clinical investigators and institutional review boards (IRB) about how to transfer the oversight of clinical trials to a new IRB. The guidance, Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board , was first released in draft form in June 2012 by FDA and the US Department of Health and Human Servic...
  • Regulatory NewsRegulatory News

    FDA Plans Meeting to Explore Regulation, Medical Uses of 3D Printing Technology

    The US Food and Drug Administration (FDA) plans to soon hold a meeting to discuss the future of regulating medical products made using 3D printing techniques, it has announced. Background 3D printing is a manufacturing process which layers printed materials on top of one another, creating three-dimensional parts (as opposed to injection molding or routing materials). The manufacturing method has recently come into vogue with hobbyists, who have been driven by several ...
  • FDA Looks for Stakeholder Input on Trials Meant to Assess Abuse of Opioids

    The US Food and Drug Administration (FDA) has experienced no shortage of criticism in recent years about its regulation of opioid-based painkillers in light of the drugs' contribution to what the Centers for Disease Control and Prevention (CDC) calls an " epidemic of prescription painkiller abuse ." But while FDA's fault (or lack thereof) is a matter of intense debate, the agency has nevertheless been taking steps in recent years meant to reduce abuse while maintaining a...
  • FDA Guidance: How to Improve Your Meetings With the Office of Orphan Product Development

    A new draft guidance document published by the US Food and Drug Administration (FDA) aims to clarify the processes and procedures of meetings with its Office of Orphan Products Development (OOPD). Background OOPD's mission is to help facilitate the development of drugs, devices, biologics and other medical products to treat patients with rare diseases. Those diseases, as defined by the Orphan Drug Act of 1983, affect fewer than 200,000 patients in the US in any given ...
  • Can FDA and Industry Give Patients and Providers the Evidence They Need to Make Informed Decisions?

    The US Food and Drug Administration (FDA) soon plans to hold a hearing on the extent to which historically under-represented subgroups of patients are included in clinical trials, and whether their lack of inclusion may have implications for the efficacy and safety of products given to those patients. Background When the  Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in 2012, among its many provisions was Section 907. The sect...
  • FDA's Influential Science Board Seeks New Members

    US regulators are calling for new nominees to serve on the US Food and Drug Administration's (FDA) Science Board , an advisory committee charged with providing advice to the agency regarding science and technology issues impacting public health. The board has been highly influential on FDA in recent years. A landmark report issued by the committee in 2007 noted serious scientific deficiencies at the agency, and led to systematic changes meant to address the concerns. ...
  • IMDRF Asks for Industry Input on Device Harmonization

    Members of the medical device industry will soon get a chance to guide the development of global medical device regulation, if only for a day. Background In a notice sent to members of the device industry on 27 January 2014, the US Food and Drug Administration (FDA) said it and fellow members of the International Medical Device Regulators Forum (IMDRF) will soon be holding a day-long stakeholders meeting. For IMDRF, this isn't a small deal. The group is the successor t...
  • As Intraocular Lenses See Technological Evolution, FDA Looks to Reassess Clinical Evaluation Methods

    The US Food and Drug Administration (FDA) has announced it plans to hold a joint workshop with the American Academy of Ophthalmology (AAO) to address challenges that affect the regulatory assessment of innovative intraocular lenses (IOLs). Background IOLs are-as their name implies-lenses that are physically implanted into the eye, most often to treat medical conditions like cataracts which otherwise disrupt the body's own crystalline lens. FDA's Federal Register noti...
  • Unique Public Meeting Set to Give One-on-One Advice to Orphan Drug, Device Developers

    Usually when the US Food and Drug Administration (FDA) meets with the public, and in particular members of industry, the meetings taking something of a group-centric approach. With lots of people likely to share similar views or benefit from hearing similar questions, the agency invites the public to listen to short presentations from public speakers before opening the floor to those who have additional, unanswered questions. But in a new and somewhat unusual announcemen...
  • FDA Plans Meeting to Assess How to Enhance Safety Monitoring of Dietary Supplements

    The safety of the pharmaceutical supply chain may be of perennial concern for regulators with the US Food and Drug Administration (FDA), but now dietary supplements are due to get some added scrutiny as well thanks to an upcoming meeting on chemical hazards. Background Unlike pharmaceuticals, dietary supplements are technically regulated more closely to food substances, avoiding the lengthy premarket approval process and the clinical trials required to generate substant...
  • FDA Looks to Harmonize Standards for Cellular, Regenerative Therapies

    The US Food and Drug Administration (FDA) has announced it will soon hold a workshop with the intent of discussing the development of "synergized" standards for cellular therapies and regenerative medicine products, saying current standards run the risk of becoming disharmonized. Background Regenerative medicine is, as its name implies, the emerging scientific field associated with the idea that cells, tissue, organs and even entire body parts can be regenerated, restor...