[ Price : $8.95]
FDA says a June inspection at Zoll Circulations Sunnyvale, CA facility found that the company failed to file MDR reports within 30...[ Price : $8.95]
CDRH says it is waiving its new refuse to accept policy until 1/1/2013 for 510(k)s while industry becomes acclimated to the FDA Sa...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance providing recommendations on bioequivalence studies for lenalidomide.[ Price : $8.95]
FDA gives LDR an approvable letter for its PMA for the Mobi-C Cervical Disc, a metal and polyethylene mobile bearing prosthesis sp...[ Price : $8.95]
CDER deputy Center director for clinical science Bob Temple tells a radio discussion FDAers are pretty excited about the ability o...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on the generic drug user fee cover sheet to the Office o...[ Price : $8.95]
CDRH warns NeuroMed Devices that it is marketing its Neuro Calm devices for treating herpes without an approved PMA or IDE.[ Price : $8.95]
The Washington Post says that people who were involved in a 2002 compounding pharmacy disease outbreak say that lessons were not l...