New events: Zika research (next week!), BSL-4 data quality training, TBI

FDA Medical Countermeasures  Initiative Update

Training: Achieving Data Quality and  Integrity in Maximum  Containment Laboratories

April 25-29, 2016
 National Institutes of Health
 Bethesda, Maryland

FDA and the University of Texas Medical Branch, Galveston National Laboratory (UTMB - GNL) collaborate to provide an annual week-long training course on how to meet Good Laboratory Practice (GLP) requirements in high and maximum biocontainment security level (BSL)-4 laboratory facilities.

FDA welcomes participants from government, industry, and academia. We welcome international participation as well; attendees in 2015 included representatives from public health agencies in Liberia, Canada, Germany, and the UK.

There are no registration fees for this course, however, seats are limited and course attendees are invited based upon diversity of roles, responsibilities, and organization.

Image: An instructor assists a participant into a BSL-4 protective suit before conducting simulated BSL-4 lab exercises during the 2015 data quality course.

How to register

If you are not a U.S. government employee, please follow these instructions to request an invitation.

If you are a U.S. government employee (FDA, NIH, DoD, etc.), a U.S. Public Health Service Officer, or a contractor working full-time at a U.S. federal agency, email Diane.Garrett@fda.hhs.gov to request an invitation. Your information and supervisory concurrence must be provided to Ms. Garrett no later than February 19, 2016 for consideration.

Related information

• More about the course

• View photos from the 2015 course

Zika virus research priorities workshop

February 16, 2016

National Academy of Sciences
Washington, DC

Research Priorities to Inform Public Health and Medical Practice for Domestic Zika Virus: A Workshop

At the request of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary of Preparedness and Response (ASPR), the National Academies of Sciences, Engineering, and Medicine and the Institute of Medicine will host a one-day public workshop to explore potential research priorities arising as a result of the emergence of Zika virus in the United States. 

Learn more and register

Global medicines regulators pledge support to tackle Zika virus diseases

The International Coalition of Medicines Regulatory Authorities (ICMRA) has pledged its support to the World Health Organization (WHO) in countering the Zika outbreak. The WHO has declared that Zika constitutes a Public Health Emergency of International Concern.

ICMRA brings together 21 medicines regulators from every region in the world, and its members are working together to fight against Zika virus disease, building on ICMRA’s collaborative work on Ebola.

Read the full statement

News updates

More events:

• February 16-17, 2016: Risk Communication Advisory Committee meeting (Silver Spring, MD and webcast) - the Committee will discuss recent developments in risk communications and related sciences, and possible approaches and applications in the context of FDA communications

• March 3, 2016: Advancing the Development of Biomarkers in Traumatic Brain Injury (Silver Spring, MD and webcast) - This workshop aims to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for traumatic brain injury (TBI). In-person participants are advised to register by 4:00 p.m. ET February 22, 2016. On-site registration may be available, if space permits.

• March 4, 2016: Vaccines and Related Biological Products Advisory Committee (Silver Spring, MD and webcast) - the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season

• April 25-27, 2016: DIA/FDA Statistics 2016 Forum  (Bethesda, MD) discussing timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs and biologics - poster abstracts  are due February 12, 2016

View more events on the frequently updated MCMi News and Events page

Guidance and information for industry:

• February 9, 2016: The FDA Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program. Pharmaceutical companies interested in participating in this program may submit proposed agendas to CDER by April 11, 2016.

• February 2, 2016: FDA's Center for Biologics Evaluation and Research (CBER) invites biologics facilities to participate in its Regulatory Site Visit Training Program (RSVP). If interested in participating, biologics facilities should contact CBER for more information byMarch 3, 2016.

• January 19, 2016: In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, CDC has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety andproposes to amend and republish the list. Comment by March 21, 2016.

• January 15, 2016: Draft guidance: Postmarket Management of Cybersecurity in Medical Devices (PDF, 952 KB) - this draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market - comment by April 21, 2016 (Federal Register notice) -Related press announcement:  FDA outlines cybersecurity recommendations for medical device manufacturers

• How to submit comments

Funding opportunities and other deadline reminders:

• FDA funds external organizations through its Broad Agency Announcement (BAA) for theAdvanced Research and Development of Regulatory Science. We are currently accepting BAA responses until February 19, 2016. Learn more and view current projects

In case you missed it:

• Zika virus resources: The Zika Virus: What You Need to Know (White House), Zika 101(HHS/CDC), Zika virus health information resources, including materials in Portuguese and Spanish (NIH/NLM) (Jan/Feb 2016)

• A U.S. Food and Drug Administration perspective on evaluating medical products for Ebola  (open access journal article in Clinical Trials) (January 14, 2016)

• FDA and NIH have published BEST glossary (Biomarkers, Endpoints & other Tools), to harmonize terms used in translational science and medical product development (January 28, 2016)

• Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance  (full article PDF, 413 KB) - journal article in Public Health Reports - Medical countermeasures (MCMs) are medical products used during public health emergencies. This study, conducted within the Mini-Sentinel Initiative, sought to develop the patient identification and matching processes necessary to assess safety outcomes for MCMs.Abstract only - more about Mini-Sentinel (Jan/Feb 2016)