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Safety Surveillance Best Practices Draft

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FDA posts for comment a draft document with best practices for agency staff in conducting postmarket safety surveillance of drugs ...

Senate Sets 11/20 FDA Confirmation Hearing

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The Senate Health, Education, Labor & Pensions Committee schedules an 11/20 confirmation hearing for FDA commissioner nominee Step...

Sandoz Neulasta Biosimilar Approved

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FDA approves Sandozs Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgens Neulasta (pegfilgrastim).

Expanded Field-of-View Laparoscope Cleared

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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...