Shares of Encysive Pharmaceuticals Inc. soared in early trading on Thursday as the pharmaceutical company said it submitted a complete response to the U.S. Food and Drug Administration regarding the company's new drug application for Thelin.
The
Houston Chronicle
Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
CoreLink’s 3D Anterior Lumbar Approved by FDA
The implant allows for better imaging by minimizing material density.
Endo Resumes Lawsuit Against FDA Over Bulk Drug Compounding Decree
The company claimed the agency’s handling of bulk compounding laws violates the 2013 Drug Quality and Security Act, treating the laws as non-binding guidance rather than a legal mandate.
FDAnews Drug Daily Bulletin
ENCYSIVE SUBMITS THELIN RESPONSE TO FDA
May 26, 2006