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Federal Register Notice: FDA releases a draft guidance providing recommendations on bioequivalence studies for lenalidomide.[ Price : $8.95]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...[ Price : $8.95]
A Tufts Center for the Study of Drug Development report says that companies are spending on average $1 million for clinical trial ...[ Price : $8.95]
Ikaria petitions FDA to revoke the orphan drug designation approved for GeNOs competing nitric oxide product for treating persiste...