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Emergency Response

October 04, 2019 | Daily News

FDA warned the public, in a consumer alert Friday (Oct. 4), to stop using vaping products that contain tetrahydrocannabinol (THC). However, one cannabis industry group argued the response from FDA seems “overly broad” as no cannabis product has been definitively proven to be the cause of the vaping-related lung injury outbreak.

September 25, 2019 | Daily News

FDA on Tuesday (Sept. 24) announced the first FDA-approved vaccine for both monkeypox and smallpox, a disease that FDA biologics director Peter Marks said many Americans have no immunity to and that could pose a national security threat if it were released intentionally.

September 20, 2019 | Daily News

President Donald Trump on Thursday (Sept. 19) issued an executive order to establish a National Influenza Task Force, co-chaired by the heads of HHS and the Department of Defense and comprising senior officials from several federal agencies, including FDA and CMS.

September 16, 2019 | Daily News

The medical countermeasure research wing of HHS chose five new groups to be part of a nationwide network meant to help boost the development of new products that could help detect illnesses, reduce the damage caused by sepsis and generally protect against public health threats, HHS announced on Monday (Sept. 16).

July 24, 2019 | Daily News

FDA on Monday (July 22) cleared a wound dressing used to treat first- and second-degree burns caused by exposure to sulfur mustard, also known as mustard gas.

June 13, 2019 | Daily News

FDA on Wednesday (June 12) issued a call for stakeholders to send pathogen samples to the agency in order to help build a database to support the rapid identification of infectious diseases in patients.

June 04, 2019 | Daily News

The House on Tuesday (June 4) passed by voice vote the Senate’s pandemic preparedness bill, which does not include a measure to reform FDA’s over-the-counter (OTC) drug regulatory framework that was part of the House’s original pandemic bill.

June 03, 2019 | Daily News

The House is moving forward with a vote this week on the Senate’s pandemic preparedness bill, which does not include a measure to reform FDA’s over-the-counter (OTC) drug regulatory framework.

May 17, 2019 | Daily News

The Senate on Thursday (May 16) passed Sen. Richard Burr’s (R-NC) pandemic preparedness bill, which reups hazard preparedness programs at HHS, but the bill, unlike the House counterpart, does not include language to reform FDA’s over-the-counter monograph regulations.

February 26, 2019 | Daily News

Three federal health agencies are forming a task force to streamline and coordinate the government’s role in making diagnostic tests available during an emergency.

January 11, 2019 | Daily News

The Senate has added to its list of active legislation the House-passed pandemic and emergency preparedness bill, which features language that would reform the way FDA regulates over-the-counter drugs and establish a user fee program for OTC products.

January 08, 2019 | Daily News

The House late Tuesday (Jan. 8) passed, for the second time in the past month, a legislative package that would both reauthorize a number of hazard preparedness programs and reform the way FDA regulates over-the-counter (OTC) drugs.

January 08, 2019 | Daily News

The House will consider on Tuesday (Jan. 8) legislation that would reform FDA’s process for regulating over-the-counter drugs and would reauthorize a number of HHS hazard preparedness programs, according to House Majority Leader Rep. Steny Hoyer’s (D-MD) daily schedule for Tuesday.

January 03, 2019 | Daily News

As the government shutdown continues into its second week and Congress works to reach a spending deal, it is still unclear what will happen to a legislative package that would reform FDA’s over-the-counter (OTC) drug oversight and reauthorize a number of hazard preparedness programs at HHS.

December 20, 2018 | Daily News

With one day left in the 115th session of Congress, the House on Thursday (Dec. 20) passed a legislative package that combines the pandemic preparedness bill with legislation that would reform the way FDA regulates over-the-counter drugs.

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).

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