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Draft Guide on Alternate eSubmission Format

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Federal Register notice: FDA makes available a draft guidance entitled Providing Regulatory Submissions in Alternate Electronic Fo...

Mixed Views on Drug Import Rule

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Four stakeholders raise varying concerns with the FDA/HHS proposal to allow some state drug importation programs.

FDA Sends Intarcia Complete Response Letter

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FDA again rejects Intarcia Therapeutics ITCA 650 exenatide implant intended to treat Type 2 diabetes.

FDA Mask, Gown Conservation Strategies

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FDA posts two documents on the potential shortage of personal protective equipment for healthcare organizations and staff during t...

Accelerated Approval for Opdivo and Yervoy

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FDA grants accelerated approval for Bristol-Myers Squibbs Opdivo and Yervoy in hepatocellular carcinoma patients who were previous...

Roche Cervical Cancer Biomarker Test Approved

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FDA approves a Roche PMA for its CINtec Plus Cytology as a biomarker-based triage test for women whose primary cervical cancer scr...

Hahn Takes Heat in Hearing on Coronavirus

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Lawmakers at an FDA appropriations hearing criticize commissioner Stephen Hahn about delays in coordinating laboratory-developed t...

Elemental Impurities Guidance Published

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FDA issues an ICH guidance on limiting elemental impurities in drug products.

Workshop on Generic Regulatory Science Initiatives

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Federal Register notice: FDA announces a 5/4 public workshop entitled FY 2020 Generic Drug Regulatory Science Initiatives.

FDA Withdraws 16 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of 16 ANDAs from multiple applicants after they notified the agency that their dru...