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SynCardia Systems begins a Class 1 recall of its Freedom Driver System because a part may fail causing the device to stop working.[ Price : $8.95]
FDA grants a qualified infectious disease product designation to Cempra, Inc. for its investigational antibiotic Taksta for treati...[ Price : $8.95]
Federal Register Notice: FDA plans to post comments submitted by individuals on the regulations.gov Web site.[ Price : $8.95]
Genentech joins AbbVie in calling on FDA to provide enhanced transparency in biosimilar labeling through a unique approach rather ...[ Price : $8.95]
Drug companies recommend some changes to a draft FDA guidance on developing drugs for acute migraine treatment.[ Price : $8.95]
FDA agrees with Pfizer on using partial area under the curve metrics as part of demonstrating bioequivalence to Quillivant.[ Price : $8.95]
CDRH adds two modules to its CDRH Learn Web site of industry training programs.[ Price : $8.95]
FDA clears a Precision Spine 510(k) for the Reform Modular and HA (hydroxyapatite) Coated Pedicle Screw System.