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Latest Blogs
- Featured Blog: May 4, 2012 posted by Barbara Lavery | 103 Views | CommentsGAO report on FDA is positive - most review goals are being met
With the current Prescription Drug User Fee Act (PDUFA) expiring in September 2012, GAO was asked to examine and report on FDA’s drug and biologic review processes. The report examines trends in FDA’s NDA and BLA review performance for 2000 through 2010, FDA’s efficacy supplement review performance, and outlines steps FDA is taking to address issues raised about review processes.
The report resulted in a conclusion that FDA is "meeting most performance goals for reviewing drug applications."
The entire GAO report can be downloaded here.
- April 3, 2012 posted by Barbara Lavery | 1506 Views | CommentsSpring time = launch time!
- February 15, 2012 posted by Barbara Lavery | 910 Views | CommentsBIO CEO 2012: Summary
Client News
- Featured Clients: January 10, 2012
- Zoomedia launches new website for Regeneron The Regeneron website www.regeneron.com positions the company as "striving relentlessly to develop new medicines for patients" and includes video pieces from the senior management team.
- May 16, 2012Ariad Announces Updated Findings from Pivotal Pace Trial of Ponatinib to Be Presented at Annual Meeting of American Society of Clinical Oncology
- May 16, 2012Rigel Advances Asthma Programs: Two Inhaled Drug Candidates Take Aim at Acute and Chronic Lung Disease
- May 15, 2012USPTO Grants Codexis Patent for Enzymes Used in Hep-C Therapeutics
- May 15, 2012Celldex Therapeutics Added to Nasdaq Biotechnology Index
