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Emergency Response

April 07, 2020 | Daily News

Tens of millions of serology tests, which analyze blood samples for antibodies to COVID-19, could be available in the United States by May, if the currently available tests are validated, HHS Assistant Secretary for Health Brett Giroir said during a White House press briefing Monday (April 6).

April 06, 2020 | Daily News

Former FDA chiefs Scott Gottlieb and Mark McClellan are pushing for the government to implement a national surveillance system for COVID-19.

April 06, 2020 | Daily News

FDA’s latest guidance on sterilization and disinfecting devices can be applied to a broad swath of decontaminating equipment, including those used in homes and businesses, and manufacturers are scrambling to meet the guidance’s requirements so equipment can be deployed quickly, according to Paul Krupin, the creator of search tool Presari.

April 01, 2020 | Daily News

After pushback from pharmacists, FDA added a footnote to its temporary March 14 compounding guidance allowing pharmacists to use food-grade alcohol, in place of the standard United States Pharmacopeia (USP)-approved alcohol, to compound hand sanitizer for the duration of the COVID-19 national emergency.

April 01, 2020 | Daily News

FDA made it easier for compounders to make hydroxychloroquine and chloroquine by adding the anti-malaria drugs to the drug shortage list Tuesday (March 31), after receiving pressure from several compounding associations for the agency to list the drugs and make the formulations available for compounding by outsourcers.

March 31, 2020 | Daily News

FDA established a program to speed reviews of COVID-19 treatments and support research on COVID-19 drug candidates, the agency announced Tuesday (March 31).

March 30, 2020 | Daily News

Kaiser Permanente’s updated chloroquine-rationing policy provides lupus patients with a 14-day refill of the drug, instead of a 90-day supply, and patients with other auto-immune diseases are being switched to alternative drugs to shore up supplies for COVID-19 patients.

March 30, 2020 | Daily News

Health care providers and health care systems that administer hydroxychloroquine sulfate and chloroquine phosphate to patients as a potential COVID-19 treatment must track adverse events and report them to FDA within seven calendar days from onset of the event.

March 27, 2020 | Daily News

Consumer diagnostic testing companies are working with FDA to get emergency use authorization for at-home COVID-19 tests and telehealth consultations with health care professionals.

March 27, 2020 | Daily News

The Trump administration is working with COVID-19 vaccine developers to start producing their vaccines before they’re proven to work, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a White House coronavirus task force briefing Thursday night (March 26).

March 26, 2020 | Daily News

FDA will not pursue enforcement action against the distribution and use for medical purposes of “improvised” face masks that have not complied with certain device regulatory requirements, the agency announced in a temporary policy released Thursday (March 26).

March 25, 2020 | Daily News

Food industry lawyers predict the United States won't experience long-term food supply chain problems even though COVID-19 is affecting staffing, retail, manufacturing and distribution of food and dietary supplements.

March 24, 2020 | Daily News

A draft Senate COVID-19 stimulus compromise floated Tuesday (March 24) maintains multiple provisions that would expand requirements for drug makers to report product shortages, give FDA authority to require device makers report shortages and potential supply disruptions, and protect manufacturers of respiratory masks from lawsuits.

March 22, 2020 | Daily News

The Senate GOP’s phase three coronavirus stimulus bill released Sunday (March 22) removes language, which had been included in a previous version of the legislative package that would allow inpatient hospitals to get paid for qualifying antibiotics under Medicare, and would require the Government Accountability Office to study possible barriers to antibiotic development.

March 19, 2020 | Daily News

The Senate’s coronavirus stimulus bill, released Thursday (March 19), encourages further development and use of antimicrobial drugs by allowing inpatient hospitals to get paid for qualifying antibiotics under Medicare.

March 19, 2020 | Daily News

FDA has postponed all routine domestic facility inspections in order to protect the health and well-being of agency staff and to address industry’s concern over visitors, FDA announced Wednesday (March 18), coming as the Trump administration advises against unnecessary travel due to the nationwide spread of COVID-19.

March 19, 2020 | Daily News

FDA issued a guidance on Wednesday (March 18) offering flexibility around clinical trial policies in a bid to maintain patient safety and test integrity amid the challenges posed by the COVID-19 pandemic, including the possibility of virtual and phone visits for trial participants.

March 18, 2020 | Daily News

Several pharmacist associations say FDA’s new guidance allowing compounding of hand sanitizers during the COVID-19 emergency falls short because key ingredients aren't available, and they ask for more flexibility in a letter to FDA Commissioner Stephen Hahn Wednesday (March 18).

March 17, 2020 | Daily News

In light of the growing coronavirus threat and reported hand sanitizer shortages, FDA announced Saturday (March 14) it will not pursue enforcement action against compounders, including pharmacists, federal facilities, or outsourcing facilities, producing hand sanitizers for consumers -- provided certain conditions are met -- until the declared national emergency has ended.

March 17, 2020 | Daily News

FDA late Monday evening (March 16) gave states authority to authorize coronavirus diagnostic tests in their own states and said private laboratories can develop and use coronavirus diagnostic tests prior to FDA approval.

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