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