[ Price : $8.95]
CDRH senior advisor for patient safety Jay Crowley says his Center is receiving push back from a number of global device makers on...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Acu-International Supplies, Alere, Avon, Bioque Technologies, CellTex Therapeuti...[ Price : $8.95]
An FDA Warning Letter lays out the basis for the agencys recent determination that Celltex Therapeutics stem cell product is subje...[ Price : $8.95]
FDAs Atlanta District Office warns Stat Rx about CGMP violations in its drug repackaging/manufacturing facility.[ Price : $8.95]
FDA warns Texas Applied Biomedical Services about continuing violations of IRB regulations and withholds approval of all new studi...[ Price : $8.95]
FDA warns DMC Medical Technology and Manufacturing Co. about Quality System Regulation violations in its manufacturing facility in...[ Price : $8.95]
A draft guidance outlines CDRHs electronic submission requirements mandated by the recently enacted Safety and Innovation Act.[ Price : $8.95]
FDA issues guidances on MDUFA 3 performance goals for PMAs and 510(k)s.