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Teleflex begins a Class 1 recall of its Babi.Plus 12.5 cm H2O Pressure Relief Manifold, which is used with its ventilators, becaus...[ Price : $8.95]
Life Spine and two of its executives agree to pay nearly $6 million to resolve kickback allegations in a whistleblower suit.[ Price : $8.95]
CDRH regulatory advisor Joshua Silverstein tells a Webinar what changes were made to the final Special 510(k) guidance in response...[ Price : $8.95]
AbbVie files a supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of younger pa...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plasti...[ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection revision entitled for Controlled Correspondence Related to G...[ Price : $8.95]
FDA revokes its orphan drug designation for Indiviors Sublocade because it was improperly granted.[ Price : $8.95]
FDA approves changes to Baraclude labeling to report data from a post-marketing safety study.