Acrux, the pharmaceutical company with unique technology for delivering drugs through the skin, today announced positive results in a US Phase 3 clinical trial of Evamist, its daily skin spray for prevention of symptoms associated with menopause. The trial was conducted by its US commercial partner VIVUS Inc., which will now proceed to file a marketing application with the US Food and Drug Administration (FDA) in the second half of 2006. Medical News Today (http://www.medicalnewstoday.com/medicalnews.php?newsid=43178)
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
Inova Diagnostics’ Assay Cleared by FDA
Inova’s test can help identify patients who are at severe risk of illness and often need aggressive immunosuppressive therapy.
Indian Drugmaker Draws FDA Warning for Adulterated Products
The firm attributed out-of-specification and out-of-trend assay results for certain tablets to sampling preparation errors but didn’t provide any evidence to support the findings.