Tips to help you get ready for emergencies | Research update for N95 Day | Zika EUA | September events

September 6, 2016  |  FDA Medical Countermeasures Initiative Update

September is National Preparedness Month

While FDA and other agencies work hard every day to help prepare the nation for potential threats, everyone can be involved in disaster readiness. Learn what you can do now, including precautions for storing water and ensuring the safety of food and medical supplies for your family and pets during and after heavy rain, possible flooding and power outages.

Related Information from FDA

• Hurricane safety checklist
• Protect food and water during storms
• Taking care of pets during a disaster or emergency
• Safe drug use after a natural disaster
• Tips about medical devices and hurricane disasters

Today is N95 Day September 6, 2016, is N95 day! Regulatory science can help ensure adequate supplies of protective equipment during emergencies. Learn about N95 Day, from CDC/NIOSH Related FDA MCMi extramural research projects: Investigating Decontamination and Reuse of Respirators in Public Health Emergencies Optimizing Respirator Decontamination to Ensure Supplies for Emergency Preparedness Image: N95 face mask respirators. These respirators protect people who wear them by removing contaminants from the air. (CDC/Debora Cartagena)

Zika Emergency Use Authorization On August 26, 2016, FDA issued an EUA for emergency use of Roche Molecular Systems, Inc.'s LightMix® Zika rRT-PCR Test for the qualitative detection of RNA from Zika virus in human serum and EDTA plasma. An EUA is a tool FDA can use to allow the use of certain medical products for emergencies based on scientific data. FDA has issued 10 EUAs for Zika diagnostic tests, as of September 6, 2016. Additional technical information about the LightMix® Zika rRT-PCR Test Zika Emergency Use Authorization information Zika virus diagnostic development Zika response updates from FDA

Guidance and information for industry

• On November 9-10, 2016, FDA will hold a public hearing - Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (Silver Spring, MD and webcast) - the purpose of this public hearing is to obtain comments on FDA's regulation of firms' communications about medical products, with a particular focus on firms' communications about unapproved uses of their approved/cleared medical products - to attend or present at the public hearing, register by October 19, 2016 - comments will be accepted until January 9, 2017
• Final Guidance - Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (PDF, 423 KB) (August 25, 2016)

Events

• New! September 7-9, 2016: Global Summit on Regulatory Science 2016 meeting on Nanotechnology Standards and Applications (Bethesda, MD)
• New! September 8, 2016: FDA Grand Rounds - Rapid On-Site Detection of Unlawful Substances in Dietary Supplements Using Ion Mobility Spectrometry - now offering CE credits
• September 12-13, 2016: Public Hearing - Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products (Bethesda, MD and webcast)
• September 12-13, 2016: Public Workshop - Pediatric Clinical Investigator Training(Bethesda, MD and webcast) - Register by September 6, 2016
• September 13-14, 2016: Public Workshop - Sequencing Quality Control II (Bethesda, MD)
• September 14-15, 2016: FDA/UM Clinical Trials Symposium: Improving Clinical Research in the Age of Precision Medicine (Coral Gables, FL) (fee)
• New! September 15-17, 2016: Public Health Law Conference  (Washington, DC) - Liz Sadove, JD, Director of Medical Countermeasure Regulatory Policy at FDA, will speak as part of a late-breaking session: Zika Virus and Emergency Legal Preparedness  (fee)
• September 23, 2016: Pediatric Master Protocols public workshop (Silver Spring, MD and webcast) - advance registration required (fee to attend in-person)
• September 23, 2016: Public Workshop - Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests (Rockville, MD and webcast)
• New! September 27-28, 2016: FDA Small Business Regulatory Education for Industry (REdI) Conference (Silver Spring, MD and webcast)

In case you missed it

• As a further safety measure against the emerging Zika virus outbreak, FDA issued a revised guidance recommending universal testing of donated whole blood and blood components for Zika virus in the U.S. and its territories. (August 26, 2016)

• FDA issues final rule on safety and effectiveness of antibacterial soaps - Rule removes triclosan and triclocarban from over-the-counter antibacterial hand and body washes (Federal Register notice) - also see the Consumer Update: FDA Taking Closer Look at 'Antibacterial' Soap (September 2, 2016)