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Teleflex Class 1 Recall of Ventilator Manifold

[ Price : $8.95]

Teleflex begins a Class 1 recall of its Babi.Plus 12.5 cm H2O Pressure Relief Manifold, which is used with its ventilators, becaus...

Life Spine, 2 Execs, Settle Kickback Case

[ Price : $8.95]

Life Spine and two of its executives agree to pay nearly $6 million to resolve kickback allegations in a whistleblower suit.

Changes in Special 510(k) Guidance

[ Price : $8.95]

CDRH regulatory advisor Joshua Silverstein tells a Webinar what changes were made to the final Special 510(k) guidance in response...

AbbVie sNDA for Imbruvica/Rituximab Combo

[ Price : $8.95]

AbbVie files a supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of younger pa...

FDA Withdraws Haemonetics ANDA

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Federal Register notice: FDA withdraws approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plasti...

Info Collection on Generic Drug Correspondence

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Federal Register notice: FDA submits to OMB an information collection revision entitled for Controlled Correspondence Related to G...

FDA Revokes Sublocade Orphan Drug Designation

[ Price : $8.95]

FDA revokes its orphan drug designation for Indiviors Sublocade because it was improperly granted.

Baraclude Label Updated with Safety Study Results

[ Price : $8.95]

FDA approves changes to Baraclude labeling to report data from a post-marketing safety study.

EIP Pharma Fast Track for Dementia Drug

[ Price : $8.95]

FDA grants EIP Pharma a Fast Track designation for neflamapimod as a treatment for dementia with Lewy bodies.

Comments Sought on Post-market Surveillance Practices

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Federal Register notice: FDA seeks comments on a draft document that details best practices for drug safety surveillance.