Neuroscience

FDA Comment Deadline: Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction

The Food and Drug Administration (FDA) seeks public comments to accompany its September 17, 2019 public hearing entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” The hearing relates to the draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs.

This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.

Members of the public may submit comments online at Regulations.gov, or via mail. More information is available at this Federal Register notice.

NASEM Workshop: Brain Health Across the Lifespan

The National Academies of Sciences, Engineering, and Medicine (NASEM), Board on Population Health and Public Health Practice, will hold a workshop titled "Brain Health Across the Lifespan." The workshop will explore issues related to brain health throughout the life span, from birth through old age. Workshop presentations will explore the following questions:

  • What are accepted definitions of brain health and resilience?
  • What are the key elements to measure status of brain health and its resilience across the life span?
  • What additional research questions can be addressed to increase our understanding of brain plasticity throughout the life span?

Members of the public may attend in person with advance registration. More information is available at this NASEM website.

DOS Meeting: Implications of Access and Benefit-Sharing Regimes on Global Health and Biomedical Research

The Department of State (DOS) will hold a meeting to discuss the implications of Access and Benefit-Sharing (ABS) regimes on global health and biomedical research. In particular, DOS will focus on the effects of Nagoya Protocol and other ABS implementation on public health systems. This is the seconf of two meetings on this topic; the first meeting will occur on June 25, 2019.

Specific issues of focus include: International research collaborations, international pathogen sample sharing, infectious disease research, including influenza, Zika and other diseases, pandemic and epidemic preparedness and response, medical countermeasure product development efforts, investor interest in vaccine development, and other aspects.

DOS would also welcome views on what the World Health Organization, other United Nations bodies, and non-governmental organizations can do to effectively protect public health equities in the context of the Nagoya Protocol and other national level ABS implementation. DOS also welcomes examples of:

  1. Monetary or non-monetary benefits to the global public health system that are facilitated by international sharing of pathogens, biospecimens, pathogen genetic sequence data, and/or relevant metadata.
  2. Influenza-specific issues and/or examples related to the items described above or other items that could affect global influenza pandemic preparedness and response or efforts to combat seasonal influenza.
  3. Non-ABS challenges and barriers with sharing pathogens internationally or that otherwise have significant implications for global pandemic or epidemic preparedness and response efforts that might merit additional attention or analysis.

Members of the public may attend in person. More information is available at this Federal Register notice and at this DOS website.

FDA Meeting: Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction

The Food and Drug Administration (FDA) will hold a public hearing entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” The hearing relates to the draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs.

This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.

Members of the public may attend in person or via webcast with advance registration. More information is available at this Federal Register notice.

FDA Meeting: Patient Engagement Advisory Committee

The Food and Drug Administration (FDA) will hold a meeting of its Patient Engagement Advisory Committee. The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. 

The Committee will discuss and make recommendations on the topic “Cybersecurity in Medical Devices: Communication That Empowers Patients.” Medical devices are increasingly connected to the internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients. These same features may also increase cybersecurity risks. Preserving the benefit of these devices requires continuous vigilance as well as timely and effective communication to medical device users about evolving cybersecurity risks. The recommendations provided by the committee will address which factors should be considered by FDA and industry when communicating cybersecurity risks to patients and to the public, including but not limited to the content, phrasing, the methods used to disseminate the message and the timing of that communication. The recommendations will also address concerns patients have about changes to their devices to reduce cybersecurity risks as well as the role of other stakeholders such as healthcare providers in communicating cybersecurity risks to patients.

Members of the public may attend in person. More information is available at this Federal Register notice.

FDA Nomination Deadline: Vaccines and Related Biological Products Advisory Committee

The Food and Drug Administration (FDA) is seeking nominations from the public and from industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Vaccines and Related Biological Products Advisory Committee within the Center for Biologics Evaluation and Research.

The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which FDA has regulatory responsibility. The committee also considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the FDA Commissioner.

Members of the public may submit nominations online at this FDA website, by email, or by mail. More information is available at this Federal Register notice.

NIH Meeting: National Institute of Neurological Disorders and Stroke, National Advisory Council

The National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), will hold the 206th meeting of its National Advisory Council.

The Council has two general functions: (1) to advise the Institute on policy and procedures affecting the extramural research programs and (2) to provide a second level of review for all grant and cooperative agreement applications considered by the Institute for funding. 

In addition to application review, the NINDS Director utilizes the expertise and experience of Council members for activities such as the following:

  • Program planning
  • Concept clearance for NINDS initiatives
  • Review of Board of Scientific Counselor reports on intramural research programs
  • Review of objectives, priorities and accomplishments of the Institute's extramural program

The Council provides the final review for all applications for research grants, training grants, and career development awards assigned to the NINDS, as well as for other requests for support for which Council approval is required by law. The Council also provides clearance for concepts for new NINDS research initiatives involving set-aside funds.

Members of the public may attend in person. More information is available at this NIH website.

FDA Comment Deadline: Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products: Content and Format

The Food and Drug Administration (FDA) is announcing the availability of and seeking public comment on a draft guidance for industry entitled “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” This guidance is intended to assist applicants in writing the DRUG ABUSE AND DEPENDENCE section of the labeling, as described in the regulations for the content and format of labeling for human prescription drug and biological products. The recommendations in this draft guidance will help ensure that the labeling is clear, concise, useful and informative, and, to the extent possible, consistent in content and format within and across drug and therapeutic classes.

This draft guidance is one in a series of guidances FDA is developing or has developed to assist applicants with the content and format of labeling for human prescription drug and biological products. In the Federal Register of January 24, 2006 (71 FR 3922), FDA published a final rule on labeling for human prescription drug and biological products. The final rule and additional guidances on labeling can be accessed online. The labeling requirements and these guidances are intended to make information in prescription drug labeling easier for health care practitioners to access, read, and use.

Members of the public may submit comments online at Regulations.gov or via mail. More information is available at this Federal Register notice.

VA / DOD Meeting: 2019 Suicide Prevention Conference

The Department of Veterans Affairs (VA) and the Department of Defense (DOD) will hold its 2019 Suicide Prevention Conference. This year’s theme "Many Roles. One Mission." emphasizes that individuals and communities have an important role in preventing suicide among Service members and Veterans. This is a top priority for the DOD and VA; however, we cannot do it on our own. We need allies and advocates in communities across the Nation to join us in making suicide prevention a priority. 

This conference will provide continuing education units, emphasize best practices and the current state of research in suicide prevention.  Experts from various disciplines will have the opportunity to cross-train in research findings, clinical pathways, and practical experiences that cannot be gained via other means.

Members of the public may attend in person with advance registration. More information is available at this VA website.