The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.

The U.S. FDA granted an emergency use authorization (EUA) for Quest Diagnostics Inc.’s self-collection kit for COVID-19. The kit allows individuals to collect their own specimens at home or in a health care setting.

New York-based at-home testing startup Letsgetchecked said Friday that the U.S. FDA has granted emergency use authorization (EUA) for its COVID-19 Sure-track Test for signs of active SARS-CoV-2 infection. The polymerase chain reaction (PCR) nasal swab test is for use by at-risk individuals in the home and delivers results within 24 hours of a sample being received by the company’s CLIA-certified laboratory.

The number of tests of various types for the SARS-CoV-2 virus are still growing, but the emergency use authorization (EUA) program is not the only option for developers. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said on the agency’s May 27 town hall that the agency would like to see test developers file for a 510(k) for their tests when the data are sufficient to support an application, adding that any such clearances will not affect the U.S. FDA’s interest in keeping plenty of similar tests on the market via the EUA mechanism.

The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.”

PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. has submitted a 510(k) application to the U.S. FDA for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The submission follows positive results from an FDA-guided bone regeneration study, which is a key component toward the goal of gaining U.S. marketing approval.

The pandemic-driven FDA guidance for device shortages addressed a topic that has been discussed for devices for some time despite lack of congressional action, but shortages may be ordinarily interpreted as a consequence of reduced or terminated production that crimps supplies. That interpretation has been expanded for the duration of the COVID-19 pandemic, however, to include circumstances in which demand exceeds supply even when the manufacturer sustains normal production levels, in which case the manufacturer is liable for reporting the shortage to the FDA.

Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said.

LONDON – Heart disease is now known to be both a cause and an effect of serious COVID-19 infection, with more than 1 in 10 patients who have underlying cardiac conditions being killed by the virus, while others with no previous record of cardiovascular problems are suffering significant COVID-19 induced weakening of their hearts.