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Pfizer Sees Rebate Issue Blocking Biosimilar Use

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Biopharma Reporter says that Pfizer CEO Albert Bourta is leading the effort to reform drug company rebates to payers that he says ...

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...

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Three stakeholders recommend improvements to an FDA draft guidance on testing and labeling medical devices for safety in the magne...