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The FDA granted just nine first-time premarket approvals in the first half of the year, down 47% from the 19 it granted in the first six months of 2012.
July 29, 2013
2 Min Read
The FDA granted just nine first-time premarket approvals in the first half of the year, down from the19 it granted in the first six months of 2012. Aside from the nine, the agency did provide a humanitarian exemption in February to Second Sight Medical's Argus II retinal prostheses system.
The author of the report published by Evaluate EP- Elizabeth Cairns - couldn't pin point the exact cause of the decline, noting that PMAs granted one year to the next do tend to fluctuate.
But the data will feed the ongoing narrative about the FDA being slow and responsible for stifling innovation.
Here's a breakdown of the PMAs and in which category they fall into, from the report:
Cardiva Medical received a PMA for its Vascade vascular closure system in January.
Lombard Medical Technologies won a PMA for its Aorfix flexible stent graft system, a graft prostheses, in February.
Allergan got a PMA for its Natrelle silicone breast implants in February.
Tenaxis Medical received a PMA for its ArterX surgical sealant in March.
Johnson & Johnson won two PMAs – one in May for its Sedasys computer-assisted sedation system, and one in June for its Mentor CPG breast implants.
Roche got a PMA for its cobas EGFR mutation test in the field of oncology molecular diagnostics in May.
bioMérieux received a PMA for its THxIDTM-BRAF assay kit also in the field of oncology molecular diagnostics, also in May
Abbott Labs received a PMA for the Abbott RealTime HCV Genotype II, RealTime HCV Genotype II control kit, in the field if infectious disease molecular diagnostics in June.
Here's a breakdown of the PMAs and in which therapy area they fall into:
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-- By Arundhati Parmar, Senior Editor, MD+DI
[email protected]
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