InvestorsHub Logo
Boards
News
Market Data
Markets
Discover
Discover
AI Subscribe Login/Register account icon
S&P 500
5,344.39
(
0.00%
)
US TECH 100
18,134.40
(
0.44%
)
Dow Jones
39,357.01
(
-0.36%
)
Brent Oil
81.83
(
0.27%
)
Bitcoin
58,562.12
(
-1.34%
)
Post# of 252864
Next 10
Reply Private New
Public Reply Private Reply New Post
Keep Last Read
Keep Next 10 Report Keyboard Shortcuts
Next 10 Prev Next

DewDiligence

Send PM Follow Ignore
Followers 835
Posts 120262
Boards Moderated 18
Alias Born 09/05/2002

DewDiligence

Member Level

Re: jq1234 post# 120024

Monday, 02/03/2014 2:11:20 PM

Monday, February 03, 2014 2:11:20 PM

Post# of 252864
(MNTA)—FDA FoB guidelines to be published in 2014:

http://t.co/x0zgEJV1SR


• Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

• Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

• Considerations in Demonstrating Interchangeability to a Reference Product

• Labeling for Biosimilar Biological Products

• Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act

The bold-faced item is probably the most consequential one for MNTA (h/t @biosimilarz).

See #msg-65845219, #msg-49883723, and #msg-26837144 for related information.

“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
Keep Last Read Next 10 Report Keyboard Shortcuts
Next 10 Prev Next
Join InvestorsHub

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.

Sign Up