Food and Drug Administration (FDA)

Rebiotix Inc. has announced it has received FDA approval on its Investigational New Drug (IND) application to begin a Phase 2 clinical study of a treatment of recurrent Clostridium difficile infection (CDI). The treatment, cialis RBX2660, ask is a “preparation containing live microbes designed to rebuild a healthy intestinal micro biome.”  If successful, the treatment […]

{ 0 comments }

Continue Reading

The U.S. Food and Drug Administration (FDA) has stated it is investigating a multi-state outbreak of Cyclospora infections. The investigation is being conducted along with the Centers for Disease Control and Prevention (CDC) and state and local officials. According to the statement, drugs the CDC and several state health departments have reported infections. As of […]

{ 0 comments }

Continue Reading

The Food and Drug Administration (FDA) has issued a Safety Alert about the voluntary recall by H&P Industries, salve Inc. of all lots of Povidone Iodine swabsticks, prep solutions, scrub solutions, and prep gel manufactured by the company. Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as an […]

{ 0 comments }

Continue Reading

The Food and Drug Administration (FDA) has issued a Drug Safety Communication for the antibiotic Zyvox, otherwise known as linezolid, an antibiotic drug used to treat certain infections. The has issued the communication in response to reports of serious central nervous system (CNS) reactions in cases where linezolid was given to patients taking psychiatric medications […]

{ 0 comments }

Continue Reading

The 2001 AAMI / FDA Medical Device Reprocessing Summit will take place at the FDA headquarters in Silver Spring, Maryland, on October 11-12, 2011. Don’t miss this timely event to address challenges recently highlighted by the U.S. Food and Drug Administration (FDA) on the reprocessing of reusable medical devices. Building from the FDA’s public meeting […]

{ 0 comments }

Continue Reading

Filligent limited has received FDA clearance for its range of surgical facemasks – BioFriend™ BioMask™ (Series A).  The market clearance was granted recently under a new medical device classification for anti-microbial surgical facemasks.  The new classification, clinic “OUK,” was created by the FDA “to accommodate Filligent’s innovations in infection control and respiratory protection,” according to […]

{ 0 comments }

Continue Reading

The U.S. Food and Drug Administration has cleared the first test for quickly identifying whether Staphylococcus aureus (S.aureus) infections are methicillin resistant (MRSA) or methicillin susceptible (MSSA).  The significance lies in the fact that there are many different kinds of Staphylococci bacteria.  Some can be easily treated with antibiotics, while others (MRSA) are resistant to […]

{ 0 comments }

Continue Reading

Roche Molecular Systems, rx Inc. has announced today that the U.S. Food & Drug Administration (FDA) has approved its new LightCycler® MRSA Advanced Test used to detect Methicillin-resistant Staphylococcus aureus (MRSA). The LightCycler® MRSA Advanced Test is a qualitative in-vitro diagnostic test used to directly detect bacterial MRSA nasal colonization.  It is specifically designed to […]

{ 0 comments }

Continue Reading