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Drug, Device Violations in Dental Technologies Inspection

[ Price : $8.95]

FDA warns Lincolnwood, IL-based Dental Technologies about CGMP and QS regulation violations at its contract drug and medical devic...

Oncologic Panel to Review Lung Cancer Therapy

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Federal Register notice: FDA announces a 2/10/2022 Oncologic Drugs Advisory Committee meeting that will vote on an Innovent Biolog...

FDA Withdraws 6 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the prod...

Info Collection on Expanded Access

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Federal Register notice: FDA seeks comments on an information collection revision entitled Expanded Access to Investigational Drug...

Pfizer Covid Oral Drug 89% Effective

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Pfizer says new data on its Covid-19 oral antiviral drug Paxlovid (nirmatrelvir tablets and ritonavir tablets) show the drug signi...

Significant HCT/P Deviations at Cooper Institute

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FDA warns Houstons Cooper Institute for Advanced Reproductive Medicine about significant deviations from the regulations for human...

Covid-19 Actemra REMS Guidance

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FDA issues a guidance modifying REMS requirements for Genentechs Actemra under certain conditions during the Covid-19-related Acte...

FDA Approves 2 Svelte Stent Systems

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FDA approves two Svelte Medical drug-eluting stent systems.

Multiple Violations Found in Sanitor Inspection

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FDA warns Stanton, CA-based Sanitor about CGMP and other violations in its manufacturing of misbranded unapproved new drugs.

QS Violations at DeVilbiss Healthcare

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FDA warns Port Washington, NY-based DeVilbiss Healthcare about Quality System regulation violations in the firms manufacturing of ...