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Emergency Response

June 17, 2021 | Daily News

FDA announced Wednesday (June 16) that it authorized an additional batch of Johnson & Johnson’s COVID-19 vaccine manufactured at Emergent BioSolutions's Baltimore facility, despite repeated health and safety hazards that occurred at the time of production and just days after Canada said it would not use donated J&J vaccines from the facility.

June 10, 2021 | Daily News

Moderna on Thursday (June 10) asked FDA to expand emergency use authorization for its COVID-19 vaccine to kids ages 12 to 17 after the two-dose mRNA vaccine was found to be 100% effective in teens. The vaccine is already authorized for use in adults ages 18 and up.

June 08, 2021 | Daily News

In a new supply chain report released Tuesday (June 8), the White House, HHS and FDA call for Congress to give FDA the power to collect information about drugs and drug ingredients moving through the U.S. supply chain, coming as the COVID-19 pandemic sheds light on several gaps in FDA’s ability to collect data on the availability of drug ingredients and respond to drug shortages.

June 04, 2021 | Daily News

FDA officials say manufacturers of COVID-19 tests that are on the market under emergency use authorization should begin submitting applications to convert their EUAs to full approval so they can stay on the market after the COVID-19 public health emergency is over.

June 04, 2021 | Daily News

FDA has granted emergency authorization for a subcutaneous injection version of Regeneron’s COVID-19 antibody therapy -- a move the agency hopes will dramatically increase access since up to now patients could only get the treatment through IV infusions.

May 26, 2021 | Daily News

FDA on Wednesday (May 26) granted emergency use authorization to GlaxoSmithKline’s investigational monoclonal antibody, sotrovimab, for treatment of patients with mild-to-moderate COVID-19.

May 19, 2021 | Daily News

Emergent BioSolutions officials blamed the manufacturing issues at the company’s COVID-19 vaccine plant in Baltimore on the unprecedented scale-up of production, missing investments and unclear intellectual property agreements, but several Democratic lawmakers noted internal documents show Emergent had multiple warnings about its facility’s shortcomings.

May 18, 2021 | Daily News

FDA on Monday (May 17) updated its inspection question-and-answer guidance with information on how it will handle drug applications, including when it will approve applications or issue complete response letters, when a physical facility inspection cannot be done due to COVID-19-related travel restrictions.

May 17, 2021 | Daily News

The U.S. government plans to share an additional 20 million doses of Pfizer’s, Moderna’s and Johnson & Johnson’s COVID-19 vaccines with other countries, President Joe Biden announced Monday (May 17).

May 17, 2021 |

The U.S. government plans to share an additional 20 million doses of Pfizer’s, Moderna’s and Johnson & Johnson’s COVID-19 vaccines with other countries, President Joe Biden announced Monday (May 17).

May 11, 2021 | Daily News

Democratic leaders of the House Energy & Commerce Committee on Tuesday pressed HHS Secretary Xavier Becerra to restore FDA’s premarket regulation of laboratory-developed tests by scrapping a Trump-era policy that revoked the agency’s jurisdiction.

May 03, 2021 | Daily News

Policy experts applauded the release of a bipartisan Senate bill that focuses on ramping up the antibiotic supply chain, but the experts say lawmakers also should focus on crafting and passing legislation that creates incentives for antibiotic developers.

April 30, 2021 | Daily News

FDA on Friday (April 30) revoked emergency use authorization for Battelle’s respirator decontamination system after the company requested voluntary withdrawal of the EUA.

April 29, 2021 | Daily News

FDA plans to issue recommendations for how diagnostics developers can seek emergency use authorization for dual-purpose COVID-19 tests that can both diagnose the disease and report to patients whether the strain detected is a variant, Timothy Stenzel, director of FDA’s office of in vitro diagnostic and radiological health, said during a Wednesday (April 28) stakeholder call.

April 27, 2021 | Daily News

Pfizer is developing an oral COVID-19 treatment that company CEO Albert Bourla expects will be available by the end of 2021.

April 22, 2021 | Daily News

During its most recent on-site inspection of Emergent BioSolutions’ Baltimore facility, FDA found that the company failed to conduct a thorough investigation into how ingredients from AstraZeneca’s COVID-19 vaccine contaminated Johnson & Johnson’s COVID-19 vaccine, and the agency says there’s also no guarantee that other batches of J&J’s product have not been cross-contaminated.

April 20, 2021 | Daily News

FDA announced Tuesday (April 20) that it will allow certain authorized COVID-19 diagnostic tests to be used to test large groups of asymptomatic people for SARS-CoV-2 on a regular basis, as long as developers can self-certify that they have validated the tests for pooling.

April 19, 2021 | Daily News

FDA’s recent notice urging health care facilities to stop using decontaminated disposable respirators doesn’t do enough to protect health care workers from COVID-19, a key nurses union says.

April 16, 2021 | Daily News

The White House said on Friday (April 16) it is investing $1.7 billion from the American Rescue plan into genomic sequencing efforts to help the Centers for Disease Control and Prevention and state governors monitor, track and defeat emerging strains of COVID-19 that are spreading rapidly in several parts of the country.

April 15, 2021 | Daily News

FDA this week released long-awaited guidance laying out the agency’s plans for tackling remote facility inspections during the COVID-19 pandemic.