FDA Medical Countermeasures

Initiative Update

New Zika Diagnostic Emergency

Use Authorization (EUA)

Gloved hands working with blood samples in lab (FDA: M. Ermarth)

On April 28, 2016, FDA authorized emergency use of Focus Diagnostics, Inc.'s Zika Virus RNA Qualitative Real-Time RT-PCR test to detect Zika virus in the blood of patients who have symptomsof Zika virus infection and live in or have traveled to an area with ongoing Zika virus transmission.

This is the first commercial test to detect Zika virus that has been authorized by FDA for emergency use.

Related information

Image: Gloved hands working with blood sample in lab. (FDA photo by Michael J. Ermarth)

Emergency Dispensing Orders

On April 13, 2016, FDA issued two Emergency Dispensing Orders to facilitate anthrax preparedness for stakeholders. FDA issued these orders in collaboration with CDC, which issued Emergency Use Instructions (i.e., fact sheets) for these two products.

The emergency dispensing order authority allows FDA to help strengthen the nation’s public healthprotections against CBRN threats by facilitating the availability and use of eligible, approved MCMs needed during public health emergencies without FDA needing to issue an Emergency Use Authorization.

Under section 564A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA may allow emergency dispensing (including mass dispensing at a point of dispensing (POD)) of approved MCMs during an actual CBRN emergency, without requiring an individual prescription for each recipient of the MCM, if (1) permitted by state law or (2) in accordance with an order issued by FDA.

Section 564A of the FD&C Act was established by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which was enacted in March 2013.

Related information

Emergency use of approved MCMs
Summary of PAHPRA's MCM provisions
Emergency Use Authorization of Medical Products and Related Authorities - draft guidance (April 2016)

Expiration Date Extensions for Certain Auto-Injectors

FDA alerts health care providers and emergency responders of expiration date extensions of certain auto-injectors manufactured by Meridian Medical Technologies.
DuoDote, AtroPen, CANA, Morphine Sulfate, and Pralidoxime Chloride auto-injectors manufactured by Meridian Medical Technologies nearing or beyond their labeled or extended expiration dates should be retained until further guidance is provided by FDA. (April 15, 2016)
More about expiration dating extensions

News updates

Events:

May 12, 2016: FDA Grand Rounds webcast - Antibiotic resistance surveillance in the age ofgenomics: New answers to old questions, presented by Patrick F. McDermott, MS, PhD, FDA Center for Veterinary Medicine

May 17-19, 2016: 14th Annual Vaccines & Therapeutics - Biodefense, Antimicrobial Resistance, Emerging Infectious Diseases , hosted by Infocast (Washington, DC) - FDA representatives will present (fee)

June 1, 2016: Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics (Silver Spring, MD, and webcast), jointly sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and FDA - registration required (fee, for some in-person participants)

July 18-19, 2016: Medical Management of Radiation Casualties: Where Research and Usage Meet (Rockville, MD), hosted by the Radiation Injury Treatment Network and the National Institute of Allergy and Infectious Diseases (NIAID)

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

Guidance and information for industry:

Final Guidance issued April 18, 2016 - Radiation Biodosimetry Medical Countermeasure Devices (PDF, 514 KB) (Federal Register notice)

FDA is seeking comments on a proposed Nonclinical Study Data Reviewer's Guide (SDRG) template. Comment by May 3, 2016.

FDA is soliciting information regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). Submit comments by May 16, 2016.

Draft Guidance for Industry and Public Health Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities - submit comments by June 3, 2016. (Federal Register notice)

FDA is announcing a 2-day public hearing September 12-13, 2016 to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps), and extending the comment period for these documents toSeptember 27, 2016.

How to submit comments

In case you missed it:

FDA published the Medical Countermeasures Initiative Program Update for fiscal year 2015, with updates on FDA's work to advance the development and availability of medical countermeasures to protect against chemical, biological, radiological, and nuclear (CBRN) threats.

In direct response to requests from the public, FDA has extended the comment period for the draft Environmental Assessment and preliminary Finding of No Significant Impact concerning investigational use of Oxitec OX513A mosquitoes. Aedes aegyptimosquitoes are known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya. The comment period will now end on May 13, 2016.

FDA posted a grant opportunity - Strengthening Partnerships with State Legislatures to Promote the Safety of FDA Regulated Products and Advance Public Health. Application closing date is July 2, 2016.

In this two-part interview, FDA's Dr. Richard Moscicki takes a deep dive into FDA’sBreakthrough Therapy designation to help clarify common misunderstandings around this expedited program. (April 18, 2016)