FDA is proposing to tighten up exemptions for custom devices under 21 CFR 812.520(b). According to the FDA Law Blog: As amended, section 520(b) will exempt[…]
On 19 July 2012, after a second evaluation which involved the adoption of a formal opinion of the Agency’s Committee for Advanced Therapies (CAT), the[…]
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[…]
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[…]