Covid-19Foreign Masks, Fear and a Fake Certification: Staff at CSL Plasma Say Conditions at Donation Centers Aren't Safe
Staff at CSL Plasma, an industry leader, raised alarms about faulty masks as donors flooded in, but the FDA and...
Covid-19Dozens of U.S. Hospitals Poised to Defy FDA's Directive on COVID Plasma
As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial...
Covid-195 Things to Know About Convalescent Blood Plasma
With all the news swirling around convalescent plasma this week, we thought we'd break it down for you.
Covid-19Public Health Experts Fear a Hasty FDA Signoff on Vaccine
Early evidence that any vaccine works would lead to political pressure from the administration for emergency approval by the FDA.
StrategyCMS Announces New CLIA Waived Tests And Their CPT Codes
Notably, Medicare pays only for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of...
Covid-19As Problems Grow with Abbott's Fast COVID Test, FDA Standards are Under Fire
The FDA has now received a total of 106 reports of adverse events for the Abbott test.
InnovationFDA Bans Certain Respirators From Being Decontaminated, Reused
Chinese-made N95 masks and respirators with exhalation tubes among banned types.
Covid-19FDA Says 4M N95 Masks Could be Reused Thanks to Emergency Order
The process has N95 masks placed in a room, sprayed with vaporized hydrogen peroxide using a special machine, and left...
StrategyGilead Backtracks on Orphan Drug Designation for Remdesivir
NIH is testing the antiviral drug's safety and efficacy against COVID-19.
InnovationFDA Takes 'Aggressive' Measures to Stimulate COVID-19 Pharmaceutical Solutions
Trump and FDA Commissioner outline mechanisms being used to access drugs, cite specific therapies that could be approved within months....
Clinical CareThe FDA Is Forcing the CDC to Waste Time Double Testing Some Coronavirus Cases
The FDA's strict guidance on test confirmations is one of several obstacles that has slowed the federal government's response to...
InnovationContest Opens to Stimulate Pediatric Device Innovations
Competition for startups aims to increase the pace of development and commercialization of critically needed pediatric medical devices.