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.
Clinical CareReports Of Patients' Deaths Linked To Heart Devices Lurk Below Radar
The FDA's registry exemption program makes key death data about heart devices inaccessible and can take up to two years...
StrategyWhy Insulin Is Ineligible for Buyer-Led Drug Importation Under Trump's Proposal
The administration points to statutory language, including definitions amended by the ACA, as preventing that FDA from allowing states to...
StrategyHHS Unveils Proposed Rule on Drug Importations
Stakeholders will have the next 75 days to comment on the proposed rule, which largely follows an outline HHS provided...
Clinical CareMedical Device Failures Brought To Light Now Bolster Lawsuits And Research
For nearly two decades, malfunctions and injuries linked to more than 100 medical devices were funneled into an FDA database...
FinanceFDA Chalks Up Record 1,171 Generic Drug Approvals
The administration set a record in fiscal year 2017, beat it in fiscal year 2018, then beat it again in...