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Siemens Healthcare Class 1 Recall of Antibiotic Tests

[ Price : $8.95]

Siemens Healthcare Diagnostics begins a Class 1 recall of its Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type...

Will Drop in CDRH Inspections Continue?

[ Price : $8.95]

Aptiv Solutions says the 2013 drop in medical device facility inspections by CDRH is not likely to continue into future years.

ContraFect Submits Response to Clinical Hold on CF-301

[ Price : $8.95]

ContraFect Corp. submits a response to FDA that it says addresses all of the issues identified in an IND clinical hold letter on C...

Dont Force Pharma to Consult FDA on Trials: LaMattina

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Former Pfizer executive John LaMattina says drug companies would be wise to consult with FDA on clinical trial protocols, but shou...

FDA OKs Amgen First to Treat Rare Leukemia

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FDA approves Amgens Blincyto, which uses the bodys T-cells to treat patients with relapsed or refractory Philadelphia chromosome-n...

Purdue Wants Updated Zolpidem BE Guidance

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Purdue Pharma asks FDA to update its draft bioequivalence guidance for zolpidem products with specific requirements for zolpidem b...

Class 1 Recall of Infant Head Supports

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FDA classifies as Class 1 a Childrens Medical Ventures (Philips Healthcare subsidiary) recall of all Gel-E Donut gel pillow and Sq...

Drug Supply Chain Enforcement Discretion Sought

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The Healthcare Distribution Management Association calls on FDA to provide more guidance or exercise enforcement discretion with t...

Guidance on SUPAC Manufacturing Equipment

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Federal Register Notice: FDA releases a guidance: SUPAC: Manufacturing Equipment Addendum.

Info on Supplement CGMPs Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on current good manufacturing practice for dietary suppl...