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Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Vital Rx.

Dova Pharma sNDA for Doptelet in ITP

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FDA accepts a Dova Pharmaceuticals supplemental NDA for Doptelet (avatrombopag) for treating chronic immune thrombocytopenia in pa...

Info Collection Extension on Expanded Access Guide

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Federal Register notice. FDA seeks comments on an information collection extension for its Guidance for Industry on Individual Pat...

Serious Deficiencies at Atlantic Pharmacy and Compounding

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FDA cautions Atlantic Pharmacy and Compounding about insanitary conditions in its production of drug products.

Use of Voluntary Consensus Standards Guidance Explained

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A CDRH Webinar explains provisions in a recent guidance on the appropriate use of voluntary consensus standards in premarket submi...

Sandoz Scraps Rituxan Biosimilar Submission

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Sandoz decides not to pursue FDA approval for its proposed biosimilar of rituximab (Genentechs Rituxan), indicated for treating so...

FDA Hits Lupin with 5-item Form 483

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FDA issues Lupin a five-item Form 483 after an inspection at the firms Madhya Pradesh, India manufacturing plant cited significant...

FDA Clears NinePoint Real-time Image Segmentation

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FDA clears a NinePoint Medical 510(k) to market its Intelligent Real-time Image Segmentation software upgrade for its NvisionVLE I...

FDA Guide on Device UDI Compliance Dates

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Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Policy Regarding Compliance Dates f...

Info Collection Extension for Biosimilar User Fees

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Federal Register notice: FDA submits to OMB an information collection extension for Biosimilars User Fee Program.