The good of the many versus the good of the individual is the age-old question that faced the FDA’s Vaccines and Related Products Advisory Committee (VRPAC) June 10 as it considered the risk-benefit issues of COVID-19 vaccines in children. Panelist Cody Meissner, director of pediatric infectious disease at Tufts Medical Center, said while he believes a vaccine is needed for children, he wants to know that the safety of the vaccine is greater than the risk of hospitalization for people younger than 18.
The FDA’s Center for Devices and Radiological Health (CDRH) issued a new document on June 8 responding to the National Institute of Standards and Technology (NIST) call for position papers to fulfill the President’s Executive Order on improving the federal government’s cybersecurity. It details how CDRH is planning to do its part to advance the shared goal within medical devices.
Developers of blood tests for the early diagnosis of Alzheimer’s disease (AD) are poised to see a spike in demand, following the FDA’s accelerated approval on Tuesday of Cambridge, Mass.-based Biogen Inc.’s AD drug treatment Aduhelm (aducanumab). The FDA’s decision paves the way for AD assays to move beyond aiding in drug development toward addressing ongoing issues with undiagnosed cases.
The FDA’s two-day advisory hearing yielded recommendations for risk designation for a number of product types, such as plunger-like joint manipulators, which received a unanimous endorsement for a class III designation. The advisory panel was split on the risks associated with electro-acupuncture stimulators, which the FDA must now decide whether to classify as a class III device, a move that would force a number of existing devices into clinical trials for an expensive and time-consuming PMA application.
Heralded as a potential turning point for U.S. innovation in the 21st century, the U.S. Innovation and Competition Act, S. 1260, is a big step closer to becoming law. The Senate voted 68-32 June 8 to pass the sweeping $250 billion bipartisan bill intended to give the U.S. an edge over China when it comes to innovation and investment in several critical industries, including artificial intelligence, biotechnology and quantum computing.
Recognizing that people with cancer want to know what symptoms they may experience and how a particular therapy may affect their quality of life, the FDA is issuing a draft guidance advising sponsors on incorporating a core set of patient-reported outcomes (PROs) into cancer clinical trials.
Phase III stakes are always high. But for Merck & Co. Inc., results of a late-stage test of its SARS-CoV-2 antiviral, molnupiravir, stand to determine not just the fate of a desired emergency use authorization (EUA), but also a $1.2 billion purchase agreement with the U.S. government pending the EUA. The RNA polymerase inhibitor, invented at Emory University and developed with Ridgeback Biotherapeutics LP, is being evaluated in a phase III study for the treatment of non-hospitalized patients with mild to moderate COVID-19. An earlier study found it unlikely to deliver clinical benefit for hospitalized patients.
Precipio Inc. reported the launch of its Hemescreen anemia panel, part of a suite of diagnostic tests that run on the Hemescreen physician office laboratory (POL) testing system. The new panel is intended to help physicians tackle a difficult challenge – deciphering anemias of unknown cause.
The FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program promises to smooth out the path from development to market access for device makers, but there are a few potential biocompatibility hiccups. Among these is that any customized preparation of a sample for biocompatibility testing would render that product ineligible for the ASCA pilot, but a product containing nanomaterials is also not eligible because of concerns over biocompatibility.