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Expanded Field-of-View Laparoscope Cleared

[ Price : $8.95]

FDA clears a 270Surgical Ltd. 510(k) for its SurroundScope System, which the company describes as the first laparoscopic camera sy...

FDAers Look at Oncology Drug Clinical Holds

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

FDA Web Page on Digital Health Reg Policies

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FDA launches a new Web page that encourages firms to inquire about the agencys current policies on digital health products.

Allergenic Products Advisory Committee Needs Rep

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Federal Register notice: FDA seeks industry organizations to participate in selecting nonvoting industry representative to serve o...

CGMP Violations at Chinas Bingbing Pharmaceutical

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FDA warns Chinas Bingbing Pharmaceutical Co. about CGMP violations in its production of finished drugs.

Drugs Approved With Manufacturing Issues: Kaiser

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A Kaiser Health News special report says FDA sometimes approves expensive innovative branded drugs despite manufacturing issues fo...

Accelerate Drug Development by 500 Days: McKinsey

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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

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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...