Health Care

FDA and Pentagon Forge Breakthrough Designation Agreement

The FDA and Department of Defense (DoD) announced a joint initiative to speed development of drugs and devices intended for use by American military personnel.

The framework for the program was established, via H.R.4374, after DoD sought to create its own review pathway whereby it could approve medical products outside of FDA's purview.

The initial phase of the program will be conducted by FDA's Center for Biologics Evaluation and Research (CBER) and Health Affairs, which will meet on a regular basis.

The steps announced Tuesday include quarterly meetings between Pentagon health leadership and CBER leadership to discuss Pentagon priorities; treating the Pentagon's priority programs as if they've received "breakthrough therapy" designation, which is a program created to expedite development and review of medical products for serious conditions; FDA-hosted workshops with the Pentagon to develop guidance on facilitating the development of products; and formal FDA-Pentagon meetings at least two times a year to review the Pentagon's product development pipeline.

More news: Naples Global Advisors LLC Buys New Holdings in Hanesbrands Inc. (HBI)

"The FDA is fully committed to working closely with our federal partners in the DoD to expedite availability of medical products essential to the health of our military service members, particularly those products used to treat injuries in battlefield settings", FDA Commissioner Dr. Scott Gottlieb said in prepared remarks.

The FDA said it expects to have a licensed product available by the end of the year.

FDA and DoD outlined their new approach to collaborate in an initial work plan, which includes treating "all priority DoD development programs as if they had received breakthrough designation" and providing "extensive manufacturing and clinical advice for prioritized products", as well as issuing guidance to facilitate the availability of products needed by DoD. "The Dept. of Defense looks forward to working with the FDA on this important program to ensure delivery of critical battlefield medicine to our service members downrange".

Using this law, FDA will work closely with Health Affairs to better understand deployed personnel's medical needs, give priority attention to and accelerate its review of priority DoD medical products, provide ongoing technical advice to Health Affairs to help in the rapid development and production of medical products for use by the military, and look closely at products now being developed and opportunities to expedite their availability.

Like this



27 January 2018
Ellington Financial LLC 2017 Q3 Institutional Investor Sentiment Worse Than Expected
On Tuesday, August 29 Hood Amy sold $4.00 million worth of Microsoft Corporation (NASDAQ:MSFT) or 55,000 shares. Reservoir Operations L.P. holds 9.76% of its portfolio in Ellington Financial LLC for 183,210 shares.

27 January 2018
"The Sportswoman In Deepika Padukone Always Trumps The Actress": Anisha Padukone
The Rajput group had claimed that the film distorts history and defames their queen Padmavati as well as Rajput pride. In Delhi-NCR, the 3D Prime category for PVR Cinemas was sold out, according to an online ticketing platform.

27 January 2018
Pakistan, Indonesia agree to bring balance in bilateral trade
Pakistan and Indonesia on Saturday agreed to exploit the untapped potential of both countries in order to strengthen trade ties. The Indonesian president will have official talks with prime minister Sheikh Hasina at her office at 10:00am on Sunday.

27 January 2018
Three boys killed as vehicle crashes into London bus stop
Witnesses claim there had been a brawl between a group of teenagers at the petrol station before the horror unfolded. Alternatively, contact the independent charity Crimestoppers on 0800 555 111, or visit

27 January 2018
Kohl's (NYSE:KSS) Rating Reiterated by Jefferies Group
Market cap is just a fancy name for a straightforward concept: it is the market value of a company's outstanding shares. Following the transaction, the director now owns 21,960 shares of the company's stock, valued at $1,182,546.

27 January 2018
Banco Bilbao Vizcaya Argentaria (BBVA) PT Set at €8.20 by Morgan Stanley
Aristotle Capital Management Llc decreased Banco Bilbao Vizcaya Argenta ( BBVA ) stake by 0.47% reported in 2017Q3 SEC filing. Shares of Banco Bilbao Vizcaya Argentaria ( NYSE:BBVA ) traded up $0.04 during midday trading on Monday, hitting $9.50.

27 January 2018
Aurora Investment Counsel Buys Shares of 58027 Nielsen NV (NLSN)
Whereas, in last 21 trading days (one month) was surged -1.07% and slashed in last 63 trading days (quarter) of -10.19%. Alternatively an RSI nearing 30 indicates that the stock could be getting oversold and might be considered undervalued.

27 January 2018
Apple (AAPL) Given a $162.00 Price Target by Barclays Analysts
Following the completion of the sale, the insider now directly owns 13,739 shares of the company's stock, valued at $2,401,302.42. Zacks Investment Research lowered Apple from a "buy" rating to a "hold" rating in a research report on Friday, January 19th.

27 January 2018
Beloved Eight-Year-Old Boy Dies From Rare Flesh-Eating Bacteria
Mommy loves you to the moon and back and I will never forget how special you were and the light that shone so bright from you". The boy's mother, Sara Hebard, said the wound wasn't a bad one and Liam just needed a few stitches.

27 January 2018
President Kenyatta finally unveils his full cabinet list
Judy Wakhungu, who was CS for Environment is the new envoy to France, while Sport's Hassan Wario will represent Kenya in Austria. Among the surprise ministries was the Chief Administrative Secretary (CAS) slot which he explained its primary role.