The CDC has posted the latest Summary of Notifiable Diseases, which contains data for the year 2010. According to the CDC, “A notifiable disease is one[…]
Osiris Therapeutics’s drug Prochymal (remestemcel-L), for acute graft-versus host disease (GvHD), has been approved for marketing by regulators in Canada. The “drug” is approved for suppressing the[…]
A clinical investigator in Florida suggests that clinical trial simulators could someday replace trials with real participants – at least to some extent. In an[…]
FDA recently published a final rule amending 21 CFR 16, 312, 511 and 812. Under the new rule, which will become effective on May 30,[…]
The FDA has approved Levaquin (levofloxacin)(Johnson & Johnson’s) for the treatment of pneumonic plague (caused by Yersinia pestis). A member of the fluoroquinolone family of drugs, it[…]
The availability of large-scale human genomic data sets raises questions regarding their proper collection, use and governance. The Presidential Commission for the Study of Bioethical Issues is currently[…]
NIH is proposing updates to the estimated reporting burdens associated with various types of submissions to ClinicalTrials.gov. The revised estimates are as follows: Applying for[…]
InfoEd Global and Maximus Announce Agreement for Integrated Research Administration Solution New MAXIMUS Effort Reporting System (ERS) Integration to Deliver Industry Standard for Interoperability In[…]