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Accelerate Drug Development by 500 Days: McKinsey

[ Price : $8.95]

A McKinsey white paper describes a holistic approach to transforming drug development that could accelerate the process by 500 day...

FDA Contracts with AnaBios for Cardiac Function Research

[ Price : $8.95]

FDA awards AnaBios an Indefinite Delivery, Indefinite Quantity contract to access its adult human primary tissues and cardiomyocyt...

CDER to Research Drug Ad Terms

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The CDER Office of Prescription Drug Promotion wants to conduct research into how consumers and primary care doctors define and in...

FDA OKs HIV Genotyping Assay

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FDA clears a de novo marketing request from Vela Diagnostics USA for its Sentosa SQ HIV Genotyping Assay for detecting human immun...

Comments on Magnetic Resonance Labeling Guidance

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Three stakeholders recommend improvements to an FDA draft guidance on testing and labeling medical devices for safety in the magne...

Medtronic MiniMed Pump Recall is Class 1

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FDA says a Medtronic recall of its MiniMed insulin pumps due to potential cybersecurity risks is Class 1.

Warren, Murray Want More Device Approval Answers

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Sens. Warren and Murray raises objections to and questions about an FDA proposal for a progressive approval pathway for medical de...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes one medical product company Bingbing Pharmaceutical.

FDAers Look at Oncology Drug Clinical Holds

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CDER researchers look at why oncology INDs are placed on clinical hold.

Fagron Recalls Lets Gel Convenience Packs

[ Price : $8.95]

Fagron recalls its Lets Gel Kit Convenience Packs due to potential microbial contamination of non-sterile products.