Human Drugs
FDA Releases Sancilio, FL Form 483
FDA releases a Form 483 after a January inspection cited significant GMP issues at Sancilio & Co.s Riviera Beach, FL manufacturing facility.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Latest Federal Register Notices
FDA Review posts Federal Register notices for the week ending 5/12/2017.
FDA General
Eyes on Gottlieb as He Heads for First Hill Testimony
Newly sworn-in FDA commissioner Scott Gottlieb visits Capitol Hill for his first testimony as the agency head 5/25 during a House budget hearing.
Medical Devices
Class 1 Recall of Abbott Catheters
FDA classifies as Class 1 an Abbott recall of specific lots of three catheters NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatati...
Human Drugs
FDA Breakthrough Status for GlycoMimetics Leukemia Drug
FDA grants a breakthrough therapy designation to GlycoMimetics for GMI-1271 and its use in treating adult relapsed/refractory acute myeloid leukemia.
Medical Devices
FDA Clears XpandOrtho Balancing Knee Surgery Device
FDA clears an XpandOrtho 510(k) for its electronic soft tissue balancing instrument for total knee replacement surgery.
FDA General
Gottlieb Talks to Staff About Scientific Advances, Priorities
In his first address to FDA staff, commissioner Scott Gottlieb talks about scientific advances that will give employees better tools to do our regulat...
Human Drugs
FDA Grants Octapharma Orphan Status for Octagam Indication
FDA grants Octapharma USA an orphan drug designation for Octagam [immune globulin intravenous (human) 10% liquid] for treating dermatomyositis.
Human Drugs
FDA Approves 2 New Indications for Mercks Keytruda
FDA approves two new indications for Mercks Keytruda (pembrolizumab) for treating certain patients with locally advanced or metastatic urothelial carc...
