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Nellcor Puritan Bennett begins a Class 1 recall of its Puritan Bennett 980 Ventilator System due to a software error.[ Price : $8.95]
CDER posts a new manual of policies and procedures document for Critical Path Innovation Meetings.[ Price : $8.95]
Repros Therapeutics reports a meeting with FDA resulted in no additional study requirements to date for its anticipated low-testos...[ Price : $8.95]
CDRH policy analyst Abiy Desta says legacy 510(k)-cleared devices that are being modified and require a new 510(k) submission will...[ Price : $8.95]
FDA revokes tentative approval decisions granted to Ranbaxy Laboratories for generic copies of AstraZenecas heartburn drug Nexium ...[ Price : $8.95]
FDA clears a Cutera 510(k) for its Enlighten laser system for tattoo removal.[ Price : $8.95]
FDAs Oncologic Drugs Advisory Committee votes 5 to 2 not to recommend approval for Novartis panobinostat, a pan-deacetylase (pan-D...[ Price : $8.95]
FDA approves a new indication for Lillys Cyramza to be used with paclitaxel to treat metastatic gastric or gastroeshopageal juncti...