FDA Medical Countermeasures Initiative Update

A Zika virus researcher at the NIAID Vaccine Research Center prepares samples. Credit: NIAID, via Flickr

Zika diagnostic Emergency Use Authorizations (EUAs)

An EUA is a tool FDA can use to allow the use of certain medical products for emergencies based on scientific data. The U.S. Secretary of Health and Human Services declared in February 2016 that circumstances exist to allow the emergency use of authorized diagnostic tests for Zika virus infection. FDA has issued 7 EUAs for Zika diagnostic tests, as of July 29, 2016.

EUAs issued in the last two weeks:

July 19, 2016 - Zika Virus Real-time RT-PCR Test (Viracor-IBT), Viracor-IBT Laboratories, Inc.
July 29, 2016 - VERSANT® Zika RNA 1.0 Assay (kPCR) Kit, Siemens Healthcare Diagnostics, Inc.

Related information

Image: A Zika virus researcher at the NIAID Vaccine Research Center prepares samples. Learn more about NIAID's Zika virus research. Credit: NIAID, via Flickr

FDA advice to blood collection establishments on non-travel related cases of Zika virus in Florida

July 27, 2016 - The Office of the ‎Florida Department of Health State Surgeon General has announced that it is conducting an epidemiological investigation into a number of non-travel related cases of Zika virus in Miami-Dade and Broward Counties. These may be the first cases of local Zika virus transmission by mosquitoes in the continental United States. Miami-Dade County and Broward County are adjacent counties in South Florida.

Read the advice to blood collection establishments

Related information

Statement from Peter Marks, MD, PhD, Director, FDA’s Center for Biologics Evaluation and Research
Safety of the Blood Supply, on our Zika virus response page
From CDC - Florida investigation links four recent Zika cases to local mosquito-borne virus transmission (July 29, 2016)
Areas with Zika, from CDC

FDA updates warnings for fluoroquinolone antibiotics

On July 26, 2016, FDA approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.

Read the press release

Related information

FDA Drug Safety Communication about fluoroquinolone antibiotics (May, 12, 2016)
Antimicrobial Drugs Advisory Committee meeting materials (see November 2015)

FDA issues draft guidance on the use of real-world evidence to support regulatory decision-making for medical devices

On July 26, 2016, FDA released a draft guidance document on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (PDF, 541 KB).

Real-world data, which are collected from sources outside of traditional clinical trials, can provide powerful insight into the benefits and risks of medical devices, including how they are used by health care providers and patients. The draft guidance gives generalized examples taken from actual uses of real-world data as valid scientific evidence for various regulatory decisions.

This draft guidance is a cornerstone of our strategic priority of creating a national evaluation system for medical devices. That system would build on and leverage the vast amount of data and information collected during the treatment and management of patients.

Submit comments on this draft guidance by October 25, 2016. If you have general questions about this guidance, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov.

Related information

News updates

Events:

August 1, 2016: Workshop - Integration of FDA and NIOSH Evaluation Processes of Respiratory Protective Devices for Health Care Workers (Washington, DC), hosted by the National Academies, Health and Medicine Division

New! August 4, 2016: CDER Small Business and Industry Assistance (CDER SBIA)Webinar: Stay Compliant! Electronic Submission of Drug Master Files (DMFs) is MANDATORY starting May 5, 2017: What You Need to Know - also see: Guidance: Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF, 111 KB)

August 8, 2016: Webinar for FDA Final Guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices, 1:00 - 2:30 p.m. ET, registration is not necessary - view the guidance (PDF, 696 KB)

New! September 8, 2016: Public Workshop - Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval (Silver Spring, MD and webcast) - register by August 1, 2016 to attend in person or view the webinar

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

More guidance and information for industry:

Draft Guidance - Principles for Codevelopment of an In Vitro Companion Diagnostic Device With a Therapeutic Product (Federal Register notice) - comment by October 13, 2016 (July 15, 2016)

Final Guidance - Adaptive Designs for Medical Device Clinical Studies (PDF, 579 KB) (Federal Register notice) (July 27, 2016)

How to submit comments

In case you missed it:

From FDA Voice: The Rise in Orphan Drug Designations: Meeting the Growing Demand - also see Designating an Orphan Product: Drugs and Biological Products (July 18, 2016)

CDC Issues Updated Zika Recommendations: Interim Guidance for healthcare providers caring for pregnant women with possible exposure to Zika virus; Interim Guidance for the prevention of sexually transmitted Zika virus (July 25, 2016)

Also from CDC, Using the Law to Prepare for Global Health Emergencies (July 25, 2016)

HHS forges unprecedented partnership to combat antimicrobial resistance - CARB-X was created to help address the threat of antibiotic resistance and it is one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antimicrobial products. (July 28, 2016)