marketing clearance

marketing clearance

Formal permission granted by the US FDA, which allows a manufacturer to produce, promote and sell a particular diagnostic or therapeutic device or product to an end-user.
References in periodicals archive ?
Orthopaedic device company 4WEB Medical reported on Wednesday the receipt of the US Food and Drug Administration's (FDA)510(k) marketing clearance for its Cervical Spine Truss System-Stand Alone (CSTS-SA) Interbody Fusion Device.
Healthcare company CrossBay Medical Inc reported on Thursday the receipt of marketing clearance to commercialise its Endometrial Tissue Sampler (ETS) using CrossGlide technology for use in endometrial biopsy procedures in Europe.
FDA seeking marketing clearance of its CarpX minimally invasive carpal tunnel release device.
On August 19, 2016, Alere announced that the Alere i RSV (respiratory syncytial virus) test received 510(k) marketing clearance from the FDA for the detection of RSV infection in children and adults.
Granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 patients in the United States, Orphan Dmg Designation enables companies to benefit from financial incentives from the FDA including seven years of market exclusivity after product marketing clearance, access to federal grant funding opportunities to defray clinical trial costs, as well as assistance with clinical protocols and federal tax credits.
Granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 patients in the United States, Orphan Drug Designation enables companies to benefit from financial incentives from die FDA including seven years of market exclusivity after product marketing clearance, access to federal grant funding opportunities to defray clinical trial costs, as well as assistance with clinical protocols and federal tax credits.
Dendreon plans to file for marketing clearance by early 2012 in Europe, where the company says the potential market is about 50% larger than the U.S.
In 2004, Spectrum Pharmaceuticals filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the FDA seeking marketing clearance for sumatriptan injection.
If the results of the study are positive, the company expects to seek marketing clearance under the FDA's 510 (k) pathway.
In 2004 Spectrum filed an ANDA containing a paragraph IV certification seeking marketing clearance for its generic version of Imitrex.
(NASDAQ:NPTH), Minneapolis, has received FDA marketing clearance for the company's steerable sheath and has signed an exclusive license and supply agreement with Bard Electrophysiology, a division of C.R.

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