[ Price : $8.95]
CBER issues a SOPP on regulatory meetings under some user fee programs.[ Price : $8.95]
GlaxoSmithKline asks FDA to look at four categories of information that have been raised in litigation over Zofran pregnancy label...[ Price : $8.95]
FDA clears a Vyaire Medical 510(k) for the bellavista 1000e ventilator.[ Price : $8.95]
CBER posts Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS).[ Price : $8.95]
Federal Register notice: FDA posts a list of eight information collections that have been approved by OMB.[ Price : $8.95]
CDER says reorganization of the Office of New Drugs moved into Phase 2 11/4.[ Price : $8.95]
FDA releases an FDA-483 with seven observations issued following an inspection at Innoveix Pharmaceuticals.[ Price : $8.95]
Biopharma Reporter says that Pfizer CEO Albert Bourta is leading the effort to reform drug company rebates to payers that he says ...