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...
Clinical CareTop 10 Medical Technology Hazards of 2020 Announced
Factors that the ECRI Institute considers in developing the medical technology hazard list include severity of risk, frequency of harm,...
Clinical CareAs Off-Label Use Spreads, Supplies Of Niche Drugs And Patients' Patience Grow Short
Nationwide, drug shortages of all kinds ? from antibiotics to heart drugs to saline solution ? are increasing and having...
FinanceJudge Vacates HHS Rule That Would Require Drug Price Disclosure in TV Ads
The ruling is likely to be challenged at the United States Court of Appeals for the District of Columbia Circuit.
Five Things We Found In The FDA's Hidden Device Database
The FDA has released two decades of previously hidden data containing millions of injuries or malfunctions by medical devices.
FDA Overlooked Red Flags In Drugmaker's Testing of New Depression Medicine
Spravato maker Janssen provided the FDA modest evidence that it worked and only in limited trials. It presented no information...
With Public Meeting, FDA Signals Interest in New Opioid Limits
Agency seeks input on possible approaches to discourage high-dose prescribing.