Tag: FDA

Scott Gottlieb resigns as head of US FDA

The commissioner of the US Food and Drug Administration (FDA), Scott Gottlieb, has unexpectedly resigned after serving just shy of two years in the...
shutdown

US government shutdown disrupting FDA work

The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept new user fees, which means the agency cannot accept new...

US FDA plan shakeup of its 510(k) clearance programme

The US FDA has announced plans to modernise its 510(k) clearance programme for approving medical devices for the US market. Data show that about...
ManaMed PlasmaFlow

ManaMed launches PlasmaFlow digital and tubeless DVT prevention device

ManaMed has introduced PlasmaFlow, the first US Food and Drug Administrator-approved portable and tubeless deep vein thrombosis (DVT) prevention device throughout the USA. "We at...

FDA grants priority review of Xarelto for a 10mg dose to...

The US Food and Drug Administration (FDA) has accepted, for priority review, a supplemental new drug application (sNDA) for Janssen’s Xarelto (rivaroxaban), to include...

FlowAid receives FDA US market clearance for the FA100 SCCD

Having received CE mark approval in July and Health Canada approval in August of last year, FlowAid Medical Technologies has now received US Food and Drug Administration (FDA)...

US FDA bans powdered gloves

The US Food and Drug Administration (FDA) has issued a final rule to ban powdered surgical gloves, patient examination gloves and the absorbable powder...

NICE collaborates with US FDA on Payer Communication Taskforce

The UK’s National Institute for Health and Care Excellence (NICE) has announced its participation in the US Food and Drug Administration (FDA)’s Payer Communication...

US FDA releases draft guidance on real-world evidence and medical device...

The US Food and Drug Administration (FDA) has released a draft guidance document entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical...