New draft guidance for anthrax emergency preparedness and response

On April 25, 2017, FDA announced the availability of a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF, 226 KB). This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. Read more

Although you can comment on any guidance at any time, to ensure that FDA considers your comment before finalizing this guidance, submit either electronic or written comments within 60 days of publication of the Federal Register notice, by June 26, 2017.

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Image: Captured inside the Strategic National Stockpile (SNS), Ebola Kit Building, this image depicts wooden pallets, which supported stacks of boxes containing personal protective equipment (PPE) items. CDC’s SNS is the nation’s largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency severe enough to cause local supplies to run out. The stockpile ensures the right medicines and supplies are available when and where needed to save lives. (Credit: CDC/Kamelya Hinson, Strategic National Stockpile Logistics Team)

Learn about FDA's research at the FDA Science Forum

Register for the FDA Science Forum

May 31 - June 1, 2017
FDA White Oak Campus, Silver Spring, MD and webcast

Learn about FDA's cutting-edge research, how the Agency applies new science and technology in regulatory decision-making, and discover how you can collaborate with FDA. The Forum includes presentations about medical countermeasure (MCM)-related research on May 31, as part of Concurrent Session 2.

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EUA Updates

Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.

EUA amendment

April 12, 2017: Aptima® Zika Virus assay (Hologic, Inc.)

More information about Zika EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, last updated in November 2016.

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Events

NEW! May 9-10, 2017: FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Spring Conference (Atlanta, GA and webcast), hosted by FDA's CDER and CDRH - the goal of this public conference is to provide direct, relevant, and helpful information on the key aspects of drug and medical device regulations in order to increase regulatory certainty and predictability for pharmaceutical and/or medical device industry
NEW! May 11, 2017: FDA Grand Rounds - Serious and Actionable Risks, Plus Disclosure: Investigating an Alternative Approach for Presenting Risk Information in Prescription Drug TV Ads, presented by Kathryn (Kit) Aikin, PhD, FDA Office of Prescription Drug Promotion, CDER
NEW! May 12, 2017: Public workshop - Roadmap for Engaging with FDA's Center for Drug Evaluation and Research (CDER) (Silver Spring, MD) - register by May 5, 2017
NEW! May 18-19, 2017: Public workshop - Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis (Silver Spring, MD), hosted by FDA, the National Science Foundation (NSF), and the Department of Homeland Security, Science & Technology (DHS S&T) - participants will discuss the current state of regulatory science in the field of cybersecurity of medical devices, with a focus on patient safety - register by 4:00 p.m. ET, May 4, 2017 (If time and space permit, onsite registration on the day of the public meeting/public workshop will be provided beginning at 8 a.m. ET.)
NEW! June 6-7, 2017: Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies: A Stand Alone Workshop (Washington, DC), hosted by the National Academies of Sciences, Engineering and Medicine, Health and Medicine Division

Information for industry

FDA and NIH release final template for clinical trial protocols - NIH and FDA have created a template to help facilitate the FDA review process for NIH-funded clinical trial protocols. Having a common template format with tailored instructions that fit each sectors’ needs will further facilitate FDA review and help increase the efficiency of the clinical trial enterprise. Along with the narrative version of the final template, NIH will also make available an electronic protocol writing tool. (May 2, 2017)

In case you missed it

FDA posted a new webpage, Use of Symbols in Labeling. The purpose of this page is to assist the public in understanding the Use of Symbols in Labeling Final Rule that became effective September 13, 2016. (April 28, 2017)
HHS seeks applications from qualified individuals for consideration for membership on the National Preparedness and Response Science Board (NPRSB) - apply by June 7, 2017 (April 20, 2017)
From NIST - New NIST data to aid production and storage of amantadine hydrochloride, which has been used as the basis for influenza antivirals, and other drugs (May 2, 2017)
From FEMA - The application period for the 2017 Federal Emergency Management Agency (FEMA) Individual and Community Preparedness Awards is now open. Apply by May 30, 2017.
From CDC - Autism and Preparedness - One of the challenges of parenting a child with autism is preparing children with special needs for public health emergencies. (May 1, 2017)
From NIH - Zika virus persists in the central nervous system and lymph nodes of Rhesus monkeys - Virus found in tissues weeks after clearance from blood (April 28, 2017), and Antibody cures animals of Ebola-related viruses (April 18, 2017)