Article: Cephalon and Eurand sue Mylan and Barr over generic Amrix.

Article: Generic drug applications plummet in China.
China Business News;  October 10, 2008 ;     625 words ...Generic drug applications plummet in China Shanghai. October ... CHINA - The number of generic drug applications in China have dropped significantly ... reduce the number of generic drug applications, along with the new provisions ...

Article: SFDA to cancel classifications of new drug ...
China Business News;  March 7, 2007 ;     545 words ... ... to cancel classifications of new drug applications Shanghai. March 7. INTERFAX-CHINA ... classifications that pertain to new drug applications, according to a top SFDA official ... to The Beijing News. At present, drug applications in China are divided into new drug ...

Article: FDA proposes changes to provide clearer information to drug ...
M2 Presswire;  July 19, 2004 ;     700+ words ... ... sponsors concerning reviews of their new drug applications(C)1994-2004 M2 COMMUNICATIONS ... complete response" letters for new drug applications would be classified by what needs ... terminology for resubmissions of generic drug applications. Under the proposal, a "major ...

Article: CHINESE GENERIC DRUG APPLICATIONS DOWN NEARLY 50 ...
AsiaPulse News;  February 16, 2009 ;     700+ words ... ... generic drugs, the number of generic drug applications dropped sharply in 2008, down nearly ... that SFDA approved 1,502 generic drug applications in 2008, involving 614 kinds of ... some extent the number of generic drug applications returns to normal, applicants tend ...

Article: FDA Revises Process for Responding to Drug ...
M2 Presswire;  July 9, 2008 ;     700+ words ... ... Revises Process for Responding to Drug Applications(C)1994-2008 M2 COMMUNICATIONS ... Thorough and timely review of drug applications is a priority of the FDA, and these ... Currently, when assessing new drug applications, the FDA can respond to a sponsor ...

Article: China Provides "Fast Track" For Certain New Drug ...
Mondaq Business Briefing;  May 6, 2009 ;     700+ words ... ... manpower to efficiently deal with drug applications in a timely manner. This has resulted ... current drug approving regime for drug applications ("Normal Application"), the ... a "Fast Track" for certain new drug applications ("Fast Track Application ...

Article: FDA REVISES PROCESS FOR RESPONDING TO DRUG ...
US Fed News Service, Including US State News;  July 9, 2008 ;     700 words ... ... Thorough and timely review of drug applications is a priority of the FDA, and these ... Currently, when assessing new drug applications, the FDA can respond to a sponsor ... the FDA to review new or generic drug applications or biologic license applications ...