Latest News
|
1 April 2013
0 Likes 
The US Food and Drug Administration (FDA) has released a fourth and long-anticipated draft guidance document pertaining to the regulatory pathway for biosimilar products, this time on how sponsors
Read More...
Latest News
|
1 February 2013
0 Likes
The European Medicines Agency (EMA) has released a draft scientific guideline on the development of biosimilar low-molecular-weight heparins, a type of medical product often used in surgical settings
Read More...
Latest News
Regulatory Update
|
22 January 2013
0 Likes
Brazil's national regulatory authority, Anvisa, has opened a Public Consultation on proposed revisions to the criteria for the technical requirements for quality, safety and efficacy needed to support
Read More...
Latest News
|
18 December 2012
0 Likes
The European Medicines Agency (EMA) has opened a new consultation on a draft guideline that would revise a set of biosimilar guidelines first put in place six years ago.The guideline, On non-clinical
Read More...
Regulatory Update
|
20 June 2012
0 Likes
The European Commission plans to allow the use of a reference product not authorized in the EU in support of a biosimilar application, according to a speech delivered by Health and Consumer Policy
Read More...
Latest News
|
31 May 2012
1 Likes
The European Medicines Agency (EMA) announced it has released a newly-revised guideline on the quality of biosimilar medicines and is soliciting comments. The 31 May 2012 guidance, Guideline on
Read More...
Latest News
|
16 May 2012
0 Likes
The US Food and Drug Administration’s (FDA) draft guidance on biosimilars attracted general praise and some pointed criticism at a public meeting held 11 May as companies jockeyed for more flexibility
Read More...
Latest News
|
26 April 2012
0 Likes
As Genetic Engineering & Biotechnology News reported in mid-April, the US Food and Drug Administration’s (FDA) draft biosimilar regulations attracted mostly negative comments. Now some companies are
Read More...
Latest News
|
16 April 2012
0 Likes
Comments on the US Food and Drug Administration’s (FDA) February 2012 draft guidance documents on biosimilar are mostly negative and reflecting discontent with the required studies to prove
Read More...
Latest News
|
11 April 2012
0 Likes
The European Medicines Agency (EMA) released a new regulatory procedure document on biosimilar medicines which it hopes will consolidate a number of regulatory and procedural questions already
Read More...