Comments on: Does Congress Need A Lesson On Biotechnology or Economics?

By: Recent Faves Tagged With "protein" : MyNetFaves

Recent Faves Tagged With "protein" : MyNetFaves — Mon, 09 Feb 2009 20:50:02 +0000

[...] >> protein Calories in K2O Protein Water First saved by HieiShadowNinjaZX | 5 days ago Does Congress Need A Lesson On Biotechnology or Economics? First saved by TennesseeHickChick | 12 days ago Protein Bars Are Not Gadgets But… First [...]

By: BiologicsMan

BiologicsMan — Thu, 02 Oct 2008 14:12:41 +0000

There is no need for a shortcut in the PHS Act..the law only requirement on FDA is that it licensure of a biolgics be based on critiera established by FDA as necessary to assure the safety, purity…of the product.

There is a long history of FDA approving new biologics based on an essentially generic basis
– blood and blood products
– allergenic products meeting compendial standards
–certain vaccines
– ….

The arguement that “biotech products” are too complicated falls apart when you consider that biologics/natural products/peptides under the FDC Act have been generics or 505b2, that there are a great many small molecular drugs that have narrow therapeutic index, complex delivery/bioavalibility and synthesis/identity issues (think warfarin, conjugated estrogens and heparin).

By: aarp

aarp — Tue, 19 Aug 2008 06:25:10 +0000

[...] the campaign by Insmed??s chief exec, Geoffrey Allan, to give Congress a lesson in biotechnologyhttp://www.patentbaristas.com/archives/2008/08/13/does-congress-need-a-lesson-on-biotechnology-or-ec…Gallatin AARP promotes medical emergency project The TennesseanThe Gallatin chapter of aarp is [...]