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Emergency Response

November 15, 2018 | Daily News

FDA on Tuesday (Nov. 13) moved toward fulfilling provisions in the 21st Century Cures Act that allow FDA to waive or alter informed consent regulations for minimal risk clinical investigations as long as there are appropriate human subject protections in place.

November 02, 2018 | Daily News

A new relationship between FDA and the Department of Defense (DOD) went official Friday (Nov. 2) with the announcement of a memorandum of agreement (MOU) that will formalize a framework agreed upon in January, under which FDA will work with DOD to accelerate access to medical products for the military.

November 01, 2018 | Daily News

Four months after authorizing emergency use of dried plasma by the Department of Defense, FDA released draft guidance that aims to spur industry interest in developing dried plasma products for use beyond the battlefield.

September 20, 2018 | Daily News

HHS Secretary Alex Azar said that the agency is not directing or encouraging states to include opioid-abuse treatment, substance-abuse treatment, or mental health benefits in short-term plans and is leaving regulation of the plans up to individual states.

September 18, 2018 | Daily News

HHS Secretary Alex Azar will chair a new cabinet-level interagency biodefense steering committee launched by the White House as part of a new National Biodefense Strategy unveiled Tuesday (Sept. 18).

June 11, 2018 | Daily News

House lawmakers introduced a draft hazard preparedness reauthorization bill that would enhance FDA’s emergency use authorities and direct the agency to work toward developing medical countermeasures with regard to cybersecurity threats.

May 23, 2018 | Daily News

The Senate health committee on Wednesday (May 23) voted 22-1 in favor of legislation reauthorizing the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, and Committee Chair Lamar Alexander (R-TN) said he hopes to get the bill through the Senate floor before programs expire in September.

February 23, 2018 | Daily News

The situation for hospitals facing shortages of saline in the wake of supply disruptions due to the spate of hurricanes in Puerto Rico is improving slightly, but shortages of amino acids are getting worse and hospitals have been left with no choice but to ration them, according to one hospital supply chain expert.

January 18, 2018 | Daily News

FDA has clarified through guidance the details of its newest voucher program, which was established through the 21st Century Cures Act and is intended to incentivize sponsors of material threat medical countermeasure (MCM) products -- those that diagnose, prevent or treat illness caused by chemical, biological, radiological and nuclear threats and emerging infectious diseases -- by expediting their review.

January 17, 2018 | Daily News

The House Energy & Commerce health subcommittee passed by voice vote on Wednesday (Jan. 17) a bill that protects health care professionals from being held liable for harm caused by providing health care services during a national or public health emergency, or a major disaster.

December 04, 2017 | Daily News

The White House Office of Management and Budget is reviewing an interim final rule on “Addressing Extreme and Uncontrollable Circumstances” for the Medicare Shared Savings program.

November 22, 2017 | Daily News

Knowledge Economy International and Doctors Without Borders (MSF) are once again sounding the alarm over a plan to issue an exclusive license for a government-developed Zika vaccine candidate.

November 21, 2017 | Daily News

The White House is asking Congress to appropriate $7.6 million in additional FDA funding for hurricane recovery, namely to pay for repair of the agency's offices in hurricane-affected areas.

November 15, 2017 | Daily News

The House on Wednesday (Nov. 15) passed by voice vote legislation that would preserve FDA's role in approving emergency medical products needed for troops -- a deal that FDA and the White House helped broker to clarify controversial language in the 2018 Defense authorization bill that would have given the emergency approval role to the Department of Defense (DOD).

November 14, 2017 | Daily News

FDA and the White House helped to broker a deal preserving the agency's role in approving emergency medical products needed for troops -- a deal that a House leadership aide told Inside Health Policy will be taken up on the House floor Wednesday (Nov. 15).

October 24, 2014 | Daily News

FDA's top official and a key biotechnology trade group official warned that the agency's flexible policies surrounding the Ebola response, including allowing the early use of investigative therapies, might not be applicable in all cases of rare diseases.

October 23, 2014 | Daily News

House Republicans' latest request for details on the Obama administration's efforts to stop the Ebola outbreak from spreading to the United States highlights the need for rapid point-of-care diagnostics.

October 21, 2014 | Daily News

The Centers for Disease Control and Prevention (CDC) has issued sweeping new guidelines for health care workers to prevent the spread of Ebola that recommend standard use of N95 or air-purifying respirators near Ebola, as opposed to earlier guidance suggesting such high-end respirators are only needed during aerosol-generating procedures. The guidance hones in on three key issues regarding use of personal protective equipment (PPE): training; ensuring no skin is exposed; and supervision of employees.

October 20, 2014 | Daily News

Industrial health experts are urgently calling on OSHA, and also taking their case directly to the White House, to move forward as rapidly as possible on a rulemaking to tackle infectious diseases in health care settings -- pressure that follows close on the heels of at least two U.S. health workers testing positive for the Ebola virus.

October 17, 2014 | Daily News

The National Nurses Union said the president's decision to tap a White House Ebola czar falls short unless the administration gives the czar power to cut off Medicare and Medicaid funds at hospitals that don't meet the highest uniform, national workplace safety standards. The union's press comes as worker health and safety advocates urge the Occupational Safety and Health Administration to step up efforts to issue a delayed infectious diseases rule that would protect health care and other workers.