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Aisa Pharma Orphan Status for Cilnidipine

[ Price : $8.95]

Aisa Pharma wins an FDA orphan drug designation for its investigational drug AISA-021 (cilnidipine) and its use in treating system...

CGMP Violations at Zydus Lifesciences Facility

[ Price : $8.95]

FDA warns Zydus Lifesciences Limited about CGMP violations in its production of finished drugs.

Multiple Optikem International Violations Cited

[ Price : $8.95]

FDA warns Denver, CO-based Optikem International about Quality System Regulation and other violations in its production of ophthal...

Changes Sought in FDA Misinformation Guidance

[ Price : $8.95]

Three trade groups representing companies regulated by FDA recommend changes to a draft guidance on addressing misinformation abou...

FDA Clears Sonic Incytes Velacur Device

[ Price : $8.95]

FDA clears Sonic Incytes Velacur Determined Fat Fraction measuring tool.

Priority Voucher Used on Incytes Opzelura

[ Price : $8.95]

Federal Register notice: FDA announces that it approved Incytes Opzelura (ruxolitinib) using a rare pediatric disease priority rev...

FDA Mulls More Post-Inspection Feedback: Cavazzoni

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CDER director Patrizia Cavazzoni tells a drug regulatory conference that FDA is considering more opportunities for sponsors to lea...

Class 2 for Endoscopic Pancreatic Debridement Devices

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Federal Register notice: FDA classifies endoscopic pancreatic debridement devices into Class 2 (special controls).

CBER Updates Refusal-to-File Procedure

[ Price : $8.95]

CBER posts an updated standard operating policy and procedure (SOPP) manual entitled SOPP 8404: Refusal to File (RTF) Procedures. ...

Cell-Free Nucleic Acid Collector is Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies blood collection devices for cell-free nucleic acids into Class 2.