• Regulatory NewsRegulatory News

    Health Canada, SwissMedic Join ICH as Steering Committee Members

    The International Conference on Harmonization (ICH), the influential international pharmaceutical regulatory harmonization body, has elected to add two new regulators to its Steering Committee, the group has announced. In an announcement on 8 July 2014, ICH said Health Canada (HC) and Swiss regulator SwissMedic would both be joining its Steering Committee "in recognition of their historical involvement and commitment to ICH." The Steering Committee, which previously onl...
  • 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    A new draft guidance document published by the US Food and Drug Administration (FDA) aims to clarify the processes and procedures of meetings with its Office of Orphan Products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...
  • 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...
  • After Supply Chain Breaches, FDA Looks to Better Communicate Risks of Counterfeits

    An upcoming advisory committee of the US Food and Drug Administration (FDA) is set to discuss how the agency can engage in best practices for communicating with health care professionals and others about the risks of counterfeit and unapproved drugs. Background US regulators have been seeing an influx of counterfeit products in recent years, testing both the limits of the security of the pharmaceutical supply chain and the ability of regulators to stop products before t...
  • FDA Re-Issues Final Guidance on Open Public Hearings, Following Unusual Process

    The US Food and Drug Administration (FDA) has released a new final guidance document regarding open public hearing sessions at the agency's advisory committee meetings, but the process by which it was published is highly unusual under the agency's good guidance practice standards. Background The final guidance, Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings , was first issued as a d...