FDA
publication date
Covid-19
Foreign Masks, Fear and a Fake Certification: Staff at CSL Plasma Say Conditions at Donation Centers Aren't SafeStaff at CSL Plasma, an industry leader, raised alarms about faulty masks as donors flooded in, but the FDA and...
Covid-19
Dozens of U.S. Hospitals Poised to Defy FDA's Directive on COVID PlasmaAs many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial...
Covid-19
5 Things to Know About Convalescent Blood PlasmaWith all the news swirling around convalescent plasma this week, we thought we'd break it down for you.
Covid-19
Public Health Experts Fear a Hasty FDA Signoff on VaccineEarly evidence that any vaccine works would lead to political pressure from the administration for emergency approval by the FDA.
Strategy
CMS Announces New CLIA Waived Tests And Their CPT CodesNotably, Medicare pays only for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of...
Covid-19
As Problems Grow with Abbott's Fast COVID Test, FDA Standards are Under FireThe FDA has now received a total of 106 reports of adverse events for the Abbott test.
Innovation
FDA Bans Certain Respirators From Being Decontaminated, ReusedChinese-made N95 masks and respirators with exhalation tubes among banned types.
Covid-19
FDA Says 4M N95 Masks Could be Reused Thanks to Emergency OrderThe process has N95 masks placed in a room, sprayed with vaporized hydrogen peroxide using a special machine, and left...
Strategy
Gilead Backtracks on Orphan Drug Designation for RemdesivirNIH is testing the antiviral drug's safety and efficacy against COVID-19.
Innovation
FDA Takes 'Aggressive' Measures to Stimulate COVID-19 Pharmaceutical SolutionsTrump and FDA Commissioner outline mechanisms being used to access drugs, cite specific therapies that could be approved within months....
Clinical Care
The FDA Is Forcing the CDC to Waste Time Double Testing Some Coronavirus CasesThe FDA's strict guidance on test confirmations is one of several obstacles that has slowed the federal government's response to...
Innovation
Contest Opens to Stimulate Pediatric Device InnovationsCompetition for startups aims to increase the pace of development and commercialization of critically needed pediatric medical devices.