Boards
News
Market Data
Markets
Discover
Discover
AI Subscribe Login/Register account icon
S&P 500
6,606.49
(
-0.27%
)
US TECH 100
23,612.00
(
-0.46%
)
Dow Jones
46,021.43
(
-0.44%
)
Brent Oil
105.03
(
0.57%
)
Bitcoin
70,700.00
(
1.15%
)
News Focus
News Focus
Post# of 257262
Next 10
Public Reply Private Reply New Post
Keep Last Read
Replies (1) Keep Next 10 Report Keyboard Shortcuts
Replies (1) Next 10 Prev Next

DewDiligence

Send PM Follow Ignore
Followers 843
Posts 122802
Boards Moderated 10
Alias Born 09/05/2002

DewDiligence

Member Level

Re: jbog post# 208181

Thursday, 01/19/2017 9:39:22 AM

Thursday, January 19, 2017 9:39:22 AM

Post# of 257262
Re: Interchangeable FoBs /indication extrapolation

The FDA has not barred indication extrapolation for interchangeable FoBs, as evidenced by the rejection of ABBV’s Citizen Petition, which is directly on-point (#msg-127947222).

Note that in the write-up you posted, the text about indication extrapolation is not a direct quotation from the guidance document.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

Public Reply Private Reply New Post
Keep Last Read
Replies (1) Keep Last Read Next 10 Report Keyboard Shortcuts
Replies (1) Next 10 Prev Next

Trade Smarter with Thousands

Leverage decades of market experience shared openly.

Join Now