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Oncologic Panel Meeting to Review Ukoniq sNDA

[ Price : $8.95]

Federal Register notice: FDA has announces a 4/21-22 Oncologic Drugs Advisory Committee meeting that will discuss the appropriate ...

Cape Drugs FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with four observations issued following an inspection at Annapolis, MD-based Cape Drugs.

AbbVie to Submit Qulipta sNDA to Expand Indication

[ Price : $8.95]

AbbVie says it will submit an sNDA to FDA to expand the indication for its Qulipta to include preventive treatment of chronic migr...

ODAC Meeting Signals Need for FDA Contact: Attorneys

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Two Morrison Foerster attorneys describe lessons learned from an Oncologic Drugs Advisory Committee meeting that voted to recommen...

Health Subcommittee to Review 20 FDA/Health Bills

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The House Energy and Commerce Committee Health Subcommittee announces a 3/17 hearing entitled The Future of Medicine: Legislation ...

FDA Clears Photon Counting Detector in CT Scanning

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FDA clears a NeuroLogica 510(k) for the addition of Photon Counting Detector technology to its OmniTom Elite 16-slice computed tom...

Supply Chain Act Drug Verification System Guidance

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FDA publishes a draft guidance with its interpretation of requirements for verification systems for certain prescription drugs und...

12 Observations in SterRx FDA-483

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FDA releases a 26-page FDA-483 with 12 observations from an inspection at Plattsburgh, NY-based StarRx outsourcing facility.

Some IVIG and IGSC Lots Withdrawn

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FDA lists lots of immune globulin intravenous and subcutaneous that have been withdrawn due to reports of allergic/hypersensitivit...

Steps FDA Could Take to Increase Trial Diversity

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A Trinity Life Sciences white paper on clinical trial diversity says FDA should change its policy and install minimum representati...