Health Care

FDA and Pentagon Forge Breakthrough Designation Agreement

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.

"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

loading...
loading...

Latest


27 January 2018
Hong Kong Bars Pro-Democracy Candidate
Agnes Chow , who is 21, is a member of the pro-democracy Demosisto political party. Chow told reporters that her disqualification was "political screening".

27 January 2018
College student, father charged in death of student's mother
Karrie, along with her Father, Lloyd, were both arrested and charged in connection with the murder on Wednesday. He was ultimately taken into custody and was awaiting extradition to NY as of the latest reports available.

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
Investors Brace For Impact: Energous Corporation (WATT), Cerecor Inc. (CERC)
They hope that the stock price will fall or that the company will fail and go bankrupt, leading the equity holders to ruin. Following the completion of the sale, the vice president now owns 83,867 shares in the company, valued at $2,783,545.73.

27 January 2018
QEP Resources (QEP) Rating Reiterated by Piper Jaffray Companies
Citigroup accumulated 0% or 947 shares. 219.29 million shares or 0.85% less from 221.16 million shares in 2017Q2 were reported. It fall, as 7 investors sold AHGP shares while 19 reduced holdings. 46 funds opened positions while 90 raised stakes.

27 January 2018
FA Cup: Conte confirms three major injury blows for Chelsea
Today with the doctor, he will have a scan to evaluate his injury but I don't think we're talking about a serious injury". Willian will miss the clash with Newcastle after suffering an injury against Arsenal . "Willian is out.

27 January 2018
Chicago Bridge & Iron Company N.v. - CBI - Stock Price Today
It dropped, as 66 investors sold PCLN shares while 320 reduced holdings. 115 funds opened positions while 384 raised stakes. It is positive, as 18 investors sold HR shares while 44 reduced holdings. 49 funds opened positions while 62 raised stakes.

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
Budweiser 2018 Super Bowl Commercial "Stand By You"
As it turns out, he's headed to Budweiser's Cartersville, George brewery where the brewery's emergency water program is based. The ad, from David Miami, features a cover of " Stand By Me " recorded by Skylar Grey specifically for the ad.

27 January 2018
IPL Auction 2018: When is it, how it works and team budgets
Each franchise will have to have a minimum of 18 players and a maximum of 25 players at the end of the auction. With ₹2 crore as the highest reserve price, 36 players, including 13 Indians, have opted for the top bracket.