FDA Medical CountermeasuresInitiative Update |
The power of randomized clinical
trials during an epidemic
 FDA Acting Chief Scientist Dr. Luciana Borio presented at TEDxUSU on how we learn if a new drug will help, hurt, or do nothing. Watch the TEDx talk Related information
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Pediatric Medical Countermeasures
New web page
FDA is working to foster the development of safe and effective medical countermeasures (MCMs) that may be needed during public health emergencies, including those for use in pediatric populations and young adults. The resources on this new web page include information about these MCMs, and some of the scientific, ethical, and regulatory issues related to the development of pediatric MCMs and public health preparedness.
PHEMCE Stakeholders Workshop - FDA Presentations
On January 6-7, 2016, HHS ASPR held a two-day workshop to highlight past progress and future directions in developing, stockpiling and effectively utilizing the drugs, vaccines, and devices that may be required in public health emergencies caused by either naturally occurring epidemics or intentional chemical, biological, radiological and nuclear attacks.
Agenda (PDF, 648 KB)
Slides from FDA presentations:
- Industry Partnerships: Linking the scientific and regulatory environments (PDF, 1.6 MB) - includes an MCM regulatory science overview, CBER MCM research and a case study on prolonging anthrax vaccine shelf life, determining MCM dose in special populations (CDER), and a regulatory perspective on infectious disease diagnostics and the FDA-ARGOS database
- Beyond The Last Mile: MCM Monitoring and Assessment during Public Health Emergencies - What capabilities do we need? (PDF, 525 KB) - presented by HHS/ASPR and FDA
- Monitoring and Assessment, FDA's Role (PDF, 231 KB)
News updates
More events:
- January 20-21, 2016: Public workshop - Moving Forward: Collaborative Approaches to Medical Device Cybersecurity (Silver Spring, MD and webcast) - seating is full for in-person attendance; registration is not required to view the webcast. More about cybersecurity of medical devices
- February 3, 2015: Eighth Annual Sentinel Initiative Public Workshop
- registration required (Washington, DC and webcast) (Federal Register notice) - more about the Sentinel Initiative
- 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
Guidance and information for industry:
- December 23, 2015: Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. FDA is announcing anopportunity for public comment on the proposed collection of certain information from product sponsors, manufacturers and public health authorities under the guidance "Emergency Use Authorization of Medical Products." The guidance describes the Agency's general recommendations and procedures for issuance of Emergency Use Authorizations(EUAs) under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 2004 (Pub. L. 108-276). Comment on this proposed information collection by February 22, 2016.
- December 23, 2015: Draft Guidance - Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base (PDF, 63 KB) - This guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging manufacturing technology. Comment by February 22, 2016. (Federal Register notice)
- December 17, 2015: Draft Guidance - Safety Assessment for Investigational New Drug Application Safety Reporting (PDF, 411 KB) - comment by February 16, 2016 (Federal Register notice)
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
- NIAID BAA - Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Biomarkers/Devices - NIAID is seeking contract proposals focused on the development of candidate medical countermeasures (MCM) or biodosimetry biomarkers/devices to assess and reduce mortality and/or major morbidities associated with exposure to radiation from a radiological or nuclear incident. Responses are due by March 22, 2016.
In case you missed it:
- In a three-part FDA Voice blog series, Acting FDA Commissioner Stephen M. Ostroff, MD, looks back at 2015, and ahead to the future. Topics include medical product innovation,medical product safety and oversight (including notes on FDA's Ebola response), and food, tobacco, and antimicrobial resistance. (January 2016)
- FDA Launches precisionFDA to Harness the Power of Scientific Collaboration - precisionFDA provides the genomics community with a secure, cloud-based platform where participants can access and share datasets, analysis pipelines, and bioinformatics tools, in order to benchmark their approaches and advance regulatory science. precisionFDA is currently in beta testing. (December 15, 2015)
- Students ages 14-23 are encouraged to participate in the HHS/ASPR My Preparedness Story Video Challenge by creating a short video (60 seconds or less) that answers the question, “How are you helping family, friends, and community to protect their health during disasters and every day?” Enter by March 28, 2016
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