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FDA approves Sandozs Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgens Neulasta (pegfilgrastim).[ Price : $8.95]
FDA clears a 270Surgical Ltd. 510(k) for its SurroundScope System, which the company describes as the first laparoscopic camera sy...[ Price : $8.95]
Public Citizen petitions FDA and the Drug Enforcement Administration to up-classify Tramadol and similar drugs from Schedule 4 to ...[ 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.