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Medical Devices

Baxter Recalls SIGMA Infusion Pumps

Baxter Healthcare recalls its SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety ...

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Federal Register

Progesterone Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that progesterone injection, USP, 50 mg/mL, was not withdrawn due to safety or effectiveness issues.

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Human Drugs

FDA Fast Tracks Invectys IVS-3001

FDA approves a fast-track designation for Invectys IVS-3001 antigen to combat renal cell cancer.

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Human Drugs

Lupin Recalls 2 Lots of Tydemy Contraceptive

Lupin Pharmaceuticals recalls two lots of Tydemy oral contraceptive tablets due to out-of-specification test results at the 12-month stability time po...

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Human Drugs

FDA, DEA Steps to Ease Rx Stimulant Shortage

FDA commissioner Robert Califf and DEA administrator Anne Milgram say they are taking multiple steps to ease a shortage of prescription stimulant drug...

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Human Drugs

Actuate Gets Orphan Status for Pancreatic Cancer

FDA grants Actuate Therapeutics an orphan drug designation for elraglusib for treating patients with pancreatic cancer.

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Human Drugs

FDA Warns Intas About Multiple Violations

FDA warns Indias Intas Pharmaceuticals about CGMP and other violations at its drug manufacturing facility in Sanand, India.

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Human Drugs

Iso-Tex Diagnostics CGMP Issues

FDA warns Alvin, TX-based Iso-Tex Diagnostics about CGMP violations in its production of finished drugs.

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Human Drugs

CGMP Violations at Baxter India Facility

FDA warns Baxters Ahmedabad, India-based drug manufacturing facility about CGMP and other violations.

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Human Drugs

Teleflex QuikClot Device Expanded Use Cleared

FDA clears a Teleflex 510(k) for expanded use for the QuikClot Control+ Hemostatic Device mild and moderate bleeding in cardiac surgical procedures a...