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Emergency Response

July 13, 2020 | Daily News

An infectious disease expert working closely with laboratories in Memphis, TN told Inside Health Policy that Poplar Healthcare received an emergency use authorization (EUA) for COVID-19 pool testing on Friday (July 10).

July 10, 2020 | Daily News

A Massachusetts-based nurses union is pushing back on the Trump administration’s calls for health care workers on the frontlines of COVID-19 response to reuse personal protective equipment, including N95 respirators.

July 10, 2020 | Daily News

FDA announced Friday (July 10) it will begin conducting announced domestic facility inspections for the first time since March.

July 09, 2020 | Daily News

The National Institute of Allergy and Infectious Diseases has merged four NIAID-funded clinical trial networks to create a new trial network that will recruit thousands of patients into large-scale clinical trials for investigational COVID-19 vaccines and monoclonal antibody therapies.

July 01, 2020 | Daily News

HHS Assistant Secretary for Health Brett Giroir told reporters Wednesday (July 1) that large-scale batch testing for COVID-19 likely will be in place and “very mature” by the time colleges reopen in August and September.

June 26, 2020 | Daily News

FDA last week told labs they could combine and test multiple patient COVID-19 diagnostic test samples using a new “pooling” technique laid out by the agency in a set of updated testing templates, coming just days before National Institute of Allergy and Infectious Diseases Director Anthony Fauci told The Washington Post that health officials were having “intense discussions” about pivoting to the new testing approach.

June 25, 2020 | Daily News

The Centers for Disease Control and Prevention on Thursday (June 25) updated its list of underlying health conditions that might increase a person’s risk of complications from COVID-19.

June 23, 2020 | Daily News

Medical device manufacturers are urging FDA to release guidance detailing the agency’s expectations for products released under emergency use authorizations (EUAs) and emergency discretion guidances once the COVID-19 public health emergency comes to a close and the temporary approvals are suspended.

June 22, 2020 | Daily News

Former U.S. Department of Agriculture Secretary Tom Vilsack said Congress should provide more financial resources to the agriculture sector and USDA to help solve issues highlighted by the current COVID-19 pandemic.

June 09, 2020 | Daily News

FDA announced Monday evening (June 8) it would adjust the Prescription Drug Marketing Act to temporarily allow for prescription medication to be distributed directly to patients through the mail in response to repeated clarification requests from the industry during the declared COVID-19 national emergency.

June 09, 2020 | Daily News

FDA announced Monday (June 8) it will temporarily allow manufacturers to mail prescription drug samples directly to patients’ homes, upon request from a health care provider, to facilitate access to medications for patients who typically obtain samples from their doctors.

June 01, 2020 | Daily News

FDA has created a voluntary online form through which certain FDA-regulated food facilities can report a temporary stop or significant slowdown in production during the COVID-19 pandemic, as well as request help from the agency on how to safely continue or restart food production.

May 28, 2020 | Daily News

Regulatory lawyers agree with former FDA chief Scott Gottlieb’s calls for the Centers for Disease Control and Prevention to release up-to-date information about COVID-19.

May 26, 2020 | Daily News

A new agreement between FDA and the U.S. Department of Agriculture solidifies USDA’s authority to invoke the Defense Production Act to force food harvesting, processing and manufacturing facilities, including plants typically regulated by FDA, to remain open during COVID-19, one food industry lawyer told Inside Health Policy.

May 21, 2020 | Daily News

Health policy experts say HHS’ move this week to expand drug manufacturing capacity in the United States through a new public-private partnership with Phlow Corporation is a good first step toward ramping up domestic production, but they also caution it’s too soon to tell whether the move will have any real, lasting impact on the overall pharmaceutical supply chain.

May 12, 2020 | Daily News

House Democrats’ latest COVID-19 response legislation, The Heroes Act (H.R. 6800), would increase FDA’s authority to secure the medical supply chain, enhance FDA’s authority to regulate medical devices, and require HHS to track the availability of COVID-19 diagnostic and serology tests.

May 07, 2020 | Daily News

National Institutes of Health Director Francis Collins suggested federal researchers should, with appropriate consent, track individuals who have tested positive for COVID-19 antibodies to see whether they develop the disease later down the road.

May 07, 2020 | Daily News

House Speaker Nancy Pelosi (D-CA) told reporters Wednesday (May 6) that the chamber’s next stimulus package will include Energy & Commerce health subcommittee Chair Anna Eshoo’s (D-CA) bill that calls for an expert committee to assess the U.S. drug supply chain and recommend ways to reduce dependence on foreign drug manufacturing.

May 06, 2020 | Daily News

FDA released a temporary guidance Wednesday (May 6) requiring that manufacturers notify the agency of any significant disruption in the medical device supply chain during a public health emergency, in a bid to mitigate devices shortage amid the COVID-19 crisis.

May 01, 2020 | Daily News

During the COVID-19 public health emergency, FDA will not require third-party certification bodies, which conduct foreign food facility inspections, to be audited in person, and the agency will allow certain certifications to extend beyond their original expiration date.