Artificial Pancreas - FDA Provides Options For Designs And Studies
A draft guidance to help artificial pancreas researchers and makers as they create and submit their devices for FDA approval has been issued by the Agency. Artificial pancreases are currently being designed and created for the treatment of diabetes type 1. The draft guidance provides flexible recommendations for the design and testing of devices so that they can still meet regulatory ...

FDA eases restrictions on GSK s Promacta, Amgen s Nplate
For the last three years, doctors prescribing the low-platelet drugs Promacta or Nplate were required to follow a strict regimen. The doctor, the pharmacist and the patient had to enroll in a monitoring program for the drugs. Doctors regularly collected and reported information on any adverse drug reactions. Due to safety concerns, the U.S. Food and [...]

Trinity Biotech Announces FDA Approval of Premier Hb9210
DUBLIN, Ireland -- Trinity Biotech plc , a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced that it has obtained FDA approval ...