Search for: "Innovative Group PMA"
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16 Apr 2013, 9:24 pm
Gorny will strengthen PMA’s initiatives to build member value in the areas of science and technology, including food-safety research, biotechnology, agricultural innovations, process and packaging technology and environmental sustainability,” said PMA. [read post]
17 Dec 2008, 6:34 pm
It’s a extremely smart and fun group to be around. [read post]
27 Sep 2010, 6:12 pm
Not every innovation is worth the time and expense of the PMA approval process. [read post]
8 Aug 2010, 8:37 pm
The reports do acknowledge the importance of enhancing innovation. [read post]
1 Nov 2007, 1:32 pm
That's why we fight the good fight in groups like PLAC and ALI - all on our own dime. [read post]
2 Sep 2017, 9:00 am
Class III devices require premarket approval (PMA). [read post]
23 Nov 2010, 1:59 am
(See: Politics, Small Farm Deal Stall Food Safety Bill, Nov. 19)Food Safety News had a chance to chat with Bob Whitaker, PMA's lead food safety expert, to discuss the group's opposition to the Tester amendment as part of the FDA Food Safety Modernization Act. [read post]
16 Aug 2011, 4:55 pm
In light of the ongoing debate over FDA’s impact on innovation, it is interesting that FDA explicitly considers novelty as a factor in favor of approval, in part to “encourage innovation. [read post]
18 Jan 2011, 10:29 pm
In conclusion, the FDA perfunctorily approved a device on the results of a fraudulent research report on which the manufacturer failed to disclose that the mortality of patients undergoing this treatment was significantly greater than that of the control group undergoing conventional treatment with clot-dissolving medication. [read post]
20 Aug 2012, 6:59 pm
Karst – Just before Congress recessed for the month of August, and less than a month after the July 9th enactment of the FDA Safety and Innovation Act, several FDA-related bills were placed in the hoppers in the U.S. [read post]
20 Aug 2012, 6:59 pm
Karst – Just before Congress recessed for the month of August, and less than a month after the July 9th enactment of the FDA Safety and Innovation Act, several FDA-related bills were placed in the hoppers in the U.S. [read post]
5 Mar 2014, 2:46 pm
Although it was originally founded by the auto industry back in 1982, it’s not an industry-specific group. [read post]
23 Apr 2012, 2:59 am
PMA wrote to President Obama earlier this month asking that the stalled rules be made public, so that the industry can have a greater degree of certainty moving forward. [read post]
22 Apr 2018, 9:00 am
” FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. [read post]
18 Feb 2018, 4:06 pm
This, in turn, spurs greater technological innovation. [read post]
2 May 2008, 7:00 am
: (Patent Baristas), US: How to avoid a permanent injunction: the lessons of Amgen v Hoffman-LaRoche: (Patent Docs), US: Jarvik Heart’s PTE request based on PMA shell/module submission dates flatlines; ruling on initiation of PTE ‘review period’ mirrors FDA policy for ‘fast track’ products: (FDA Law Blog) Pharma & Biotech - Products Kytril (Granisetron) – Exclusivity ‘parking’ still… [read post]
6 Nov 2009, 9:26 pm
Just as the Bush memos attempted to justify the previous Administration's harsh interrogation methods in the name of national security and the President's broad powers as Commander-in-Chief, likewise, the Total Attorneys Response suggests (perhaps unintentionally) that because its pricing model is part of the great wave of innovative and enlightened Internet-enabled marketing practices, conventional ethics standards must give way to progress. [read post]
5 Aug 2010, 2:08 pm
Basically no alternative “acellular” DTP vaccine received FDA approval for use in the relevant age group until 1996 – 4 years after the injury claimed in Bruesewitz.The Vaccine Act, Wyeth points out, was drafted partly in response to the proliferation of such “design defect” claims. [read post]
