FDA Offers 2016 Report on Medical Countermeasure Activities


Posted 20 Mar 2017
By Zachary Brennan

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As part of efforts to strengthen the US opposite chemical, biological, radiological, and arch (CBRN) threats, the US Food and Drug Administration (FDA) authorized 7 new treatments and 21 new inclination in FY 2016, according to a module refurbish on medical countermeasure (MCM) activities.

With a bill of a little more than $110 million, FDA’s MCM efforts play a critical role in safeguarding the US from dangerous threats and rising spreading illness threats, such as pestilence influenza, Ebola virus illness and Zika virus infections. The group is obliged for assessing the reserve and efficacy of MCMs —including drugs, healing biologics, vaccines and devices, such as evidence tests—to opposite these threats.

“FDA continues to respond to rising open health threats in an rare way. The comfortless Ebola widespread in West Africa was announced over in early 2016, and the World Health Organization (WHO) announced in Nov 2016 that Zika is no longer an general open health emergency,” Luciana Borio, MD, FDA’s behaving arch scientist, pronounced in a statement. “However, this doesn’t meant that these diseases are no longer a concern. Vaccines for Ebola are still underneath development. WHO has identified—and the tellurian open health village agrees—that Zika is a critical open health emanate that will need postulated and long-term efforts relocating forward. We contingency continue to assist growth of MCMs to detect, treat, and forestall rising diseases—particularly Zika, which is expected to turn autochthonous in much of North America, with harmful and life-altering consequences for some of our most exposed populations.”

As a means of enlivening serve MCM development, the new 21st Century Cures law also creates a new priority examination document program for MCM sponsors.

2016 Approvals

In the area of MCMs to yield diseases or conditions caused by CBRN threats, FDA approved the monoclonal antibody Anthim (obiltoxaximab) to yield inhalational anthrax in multiple with suitable antibacterial drugs. FDA also expanded the indication for BioThrax (Anthrax Vaccine Adsorbed) to embody post-exposure treatment (PEP) of illness ensuing from suspected or confirmed B. anthracis exposure.

For pestilence influenza preparedness, FDA approved Fluad, the first anniversary influenza vaccine containing an adjuvant. FDA also authorized 5 new nucleic acid-based influenza tests: 3 qualitative in vitro diagnostic (IVD) tests for the showing and split of influenza A, influenza B and respiratory syncytial viruses (ARIES Flu A/B RSV Assay, Cobas Influenza A/B RSV, and Xpert Flu+RSV); a qualitative IVD exam for the showing and split of influenza A and B viral RNA (Solana Influenza A+B Assay); and a multiplexed device for the qualitative showing of influenza A (with sub-type differentiation), influenza B, and other respiratory viruses and germ (NxTag Respiratory Pathogen Panel). 

On the jeopardy preparedness front, FDA authorized the Ahead 300 device, which analyzes a patient’s electroencephalograph using a sensor trustworthy to a smartphone to yield an interpretation of the constructional condition of the patient’s mind after a conduct repairs at the point of care.

In the area of diagnostics for CBRN threats, FDA authorized a Shiga Toxin Direct Test for the showing of nucleic acids and venom gene sequences found in Shiga venom producing strains of E. coli 0157 and Shigella dysenteriae, in sofa specimens. And for re-emerging threats, FDA authorized 3 modifications to a Bordetella pertussis assay.

Regulatory Science

In FY 2016, FDA continued to exercise its MCMi Regulatory Science Program with collaborative investigate and partnerships with supervision agencies, academia and industry. Examples of swell include:

  • Developing models of deviation repairs in lung, gut, and bone marrow organs-on-chips and then using these models to exam claimant MCMs to yield such repairs
  • Developing diagnostics that can detect botulism neurotoxin at low levels in food
  • Evaluating the use of chimeric viruses to urge prolongation of influenza B vaccines.

MCMi Fiscal Year 2016 Program Update

Article source: http://www.raps.org/Regulatory-Focus/News/2017/03/20/27156/FDA-Offers-2016-Report-on-Medical-Countermeasure-Activities/

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