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defensedepartment

FDA to speed up review of medical products for U.S. military

November 2, 2018 By Chris Newmarker

The U.S. FDA today announced a memorandum of understanding with the Department of Defense to accelerate regulatory assessment of medical products for military personnel. Congress last year passed a law to expedite regulatory review of products to diagnose, treat or prevent serious diseases or conditions facing U.S. military personnel. The memorandum establishes a framework to implement […]

Filed Under: Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: defensedepartment, FDA, U.S. Department of Defense

Report: MiMedx held lower-cost grafts from federal hospitals

October 5, 2018 By Brad Perriello

MiMedx (NSDQ:MDXG), already embroiled in an internal accounting snafu and several federal probes, reportedly held from government hospitals some of the lower-cost products it made available to private hospitals. In limiting its regenerative wound care offering to U.S. Veteran Affairs Dept. and other federal caregivers, Marietta, Ga.-based MiMedx ran up the tab on taxpayers, the Wall […]

Filed Under: Featured, Legal News, Regenerative Medicine, Wound Care Tagged With: defensedepartment, MiMedx Group Inc., U.S. Veterans Affairs Dept. (VA)

FDA grants DoD approval for freeze-dried plasma on the battlefield

July 10, 2018 By Fink Densford

The FDA said today it granted an emergency use authorization to the US Department of Defense for the use of particular freeze-dried plasma products designed for the treatment of hemorrhage or coagulopathy. The approval specifically covers the use of pathogen-reduced leukocyte-depleted freeze-dried plasma produced by the Centre de Transfusion Sanguine des Armées, known in the […]

Filed Under: Blood Management, Food & Drug Administration (FDA), Wound Care Tagged With: defensedepartment

FDA, Pentagon reveal plan to speed medical devices, drugs to military personnel

January 16, 2018 By Brad Perriello

The FDA and the Pentagon said today that they’re launching a joint program to speed the development of medical products for military personnel. The federal safety watchdog and the Defense Dept.’s Office of Health Affairs said the program’s framework is based on a House bill passed last year that expands the FDA’s authority to approve the […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: defensedepartment

Carefusion wins $50m Pentagon contract

December 22, 2017 By Brad Perriello

Becton Dickinson & Co. (NYSE:BDX) subsidiary CareFusion won a U.S. Defense Dept. contract worth nearly $50 million, the Pentagon said yesterday. San Diego-based Carefusion Solutions won the five-year, $49.5 million contract for medical equipment. The firm-fixed-price with economic-price-adjustment deal was awarded after the military reviewed bids from 31 suitors and is good to Dec. 20, 2022. The Pentagon […]

Filed Under: Wall Street Beat Tagged With: americanmedicaldepot, becton dickinson, CareFusion Corp., defensedepartment

Pentagon re-ups $14m General Electric contract for patient monitoring systems

December 21, 2017 By Brad Perriello

The U.S. Defense Dept. yesterday said it’s picking up the ninth renewal of a contract with the patient monitoring business at GE Healthcare (NYSE:GE) that’s worth more than $14 million. Wauwatosa, Wis.-based GE Medical Systems Information Technology won the one-year renewal for the $14.4 million deal to provide patient monitoring systems, subsystems, accessories, consumables and training to […]

Filed Under: Patient Monitoring Tagged With: defensedepartment, GE Healthcare

House approves FDA fast track for battlefield treatments

November 16, 2017 By Brad Perriello

The U.S. House of Representatives yesterday approved a measure that would create a fast track at the FDA for medical devices and drugs intended for treating battlefield injuries, a day after passing a nearly $700 billion defense policy bill that would have allowed Defense Dept. to approve the treatments without the FDA’s participation. That provision […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: defensedepartment, U.S. House of Representatives

House passes DoD bill with room to renegotiate drug, device approval provision

November 15, 2017 By Fink Densford

The US House of Representatives this week passed a nearly $700 billion defense policy bill, but left room for negotiating new terms related to a controversial provision which would have given the Dept. of Defense the power to approve medical devices and drugs without FDA clearance. The house voted 356 to 70 to approve the […]

Filed Under: Food & Drug Administration (FDA), Healthcare Reform, Regulatory/Compliance Tagged With: defensedepartment

Report: Proposed DoD health committee could undermine the FDA

November 7, 2017 By Fink Densford

A new defense policy bill would give the US Department of Defense the power to approve drugs and medical devices without FDA clearance, according to a report from Politico. The bill has alarmed congressional health staff and the Dept. of Health and Human Services who claim it could erode medical safety, putting US soldiers at […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: defensedepartment, Dept. of Health & Human Services (HHS)

Cardinal Health, Hamilton Medical, Zoll Medical score DoD contracts

October 2, 2017 By Chris Newmarker

Cardinal Health (NYSE: CAH) will receive $29.2 million under a new U.S. Department of Defense contract, with Hamilton Medical and Zoll Medical also securing contracts in the tens of millions of dollars. Cardinal Health’s contract win, announced Sept. 29, comes nearly eight months after Dublin, Ohio–based Cardinal Health secured a $2.25 billion surgical supplies contract […]

Filed Under: Business/Financial News, News Well Tagged With: Cardinal Health, defensedepartment, Hamilton Medical, Humacyte, Zoll Medical

Defense Dept. awards DePuy $33m deal for surgical products

September 26, 2017 By Alex Beall

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes secured a $32,994,565 contract from the U.S. Department of Defense for medical surgical products last week. The nine-month contract comes with eight one-year and one 15-month option periods. The customers include the Army, the Navy, the Air Force, the Marine Corps and federal civilian agencies. Earlier this month, DePuy launched […]

Filed Under: Business/Financial News, Surgical Tagged With: defensedepartment, depuysynthes, Johnson and Johnson

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