The Biden administration has released an exceedingly brief budget framework for fiscal year 2022 that includes $6.5 billion for an advanced research program at the NIH, which mimics a similar program at the Department of Defense (DoD). Beyond that, there is a clear indication that the CDC would see an uptick in monies, but the proposal offers no numbers for the FDA budget, making this one of the skinnier budget proposals to come out of the White House in recent memory.
The administration of President Joseph Biden announced March 17 a $10 billion allocation of funds for testing to reopen schools in the final months of the current school year, a source of revenues that was provided by the recently passed $1.9 trillion American Rescue Plan. The news follows by one day a new FDA policy on screening tests that allows test developers to distribute tests designed to screen those who are asymptomatic without first validating the test for this use, although there are still questions as to whether this new push will yet again crimp vital testing supplies.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA blasts thermographic sensor system marketers; WHO to tackle breast cancer globally; PhRMA urges Biden to stand by IP rights; FDA ASCA workshop announced.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MHRA lists premarket requirements; OIG says up-coding may be driving more expensive admissions; TGA tees up Haimex; White House calls for 100-day review for supply chain.
The Biden administration said it will use the U.S. Defense Production Act to grapple with the COVID-19 pandemic in a plan that includes a large increase in vaccine purchases. Also on tap is an increase in production of at-home test by six companies in addition to Ellume Ltd., of Perth, Australia, which will ship more than 8 million of their tests to the U.S. by the end of the year.
U.S. FDA warning letters have been a staple of regulatory life since the late 1990s, but James Boiani, a regulatory attorney with Epstein, Becker & Green P.C., said it’s no stretch of the imagination that warning letter volumes will jump in 2021. This is to some extent because the volume of warning letters dropped significantly over the past four years, and Boiani advised that all FDA-regulated industries will see more warning letters unless they are communicative with the agency about inspectional findings.
The U.S. FDA’s safer technologies program, or STeP, may seem uncontroversial, but agency staff said on a Feb. 1 conference call that the program could be delayed by the change in administration at the White House. This is possibly an artifact of the Biden administration’s Jan. 20 executive order (EO) that applies a freeze to federal agency activities for 60 days, an EO that could affect a wide swath of federal agency activity.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Krishnamoorthi eyes ventilator contract; TGA fines company for failure to provide masks; U.S. PPE hoarder indicted; CAP supports Defense Production Act; South African variant in U.S.; GAO: More needs to be done to respond to COVID-19; Biden orders review of scientific-integrity policies.