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Staska Pharma Hit with FDA Form 483

[ Price : $8.95]

An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.

FDA Guide on Developing Drugs for Pulmonary Tuberculosis

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FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, e...

FDA Delays Review Action on Alzheimers Drug

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FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation of Alzheimers drug Leqembi (l...

Legal Analysis Highlights Impact of FDA AI Clinical Trial Pilot

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A legal analysis published by Crowell & Moring says a proposed FDA pilot program on artificial intelligence in early-stage clinica...

Trump Denies Makary is on the Outs

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President Trump tells reporters he knows nothing about reports suggesting FDA commissioner Marty Makary will be asked to resign so...

FDA Input Sought on Drug Repurposing

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FDA seeks public input on ways to expand drug repurposing efforts, aiming to accelerate treatment options for patients with unmet ...

Guide on Developing Clostridioides Difficile Infection

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FDA issues updated guidance for companies developing therapies to treat, prevent or reduce recurrence of Clostridioides difficile ...

Postapproval Pregnancy Safety Studies Guidance Available

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FDA releases a new guidance outlining how drugmakers should design and conduct postapproval studies evaluating the safety of drugs...

Guide on Submitting Continuous Glucose Monitoring Data

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FDA posts new technical guidance document outlining how sponsors should submit continuous glucose monitoring data collected during...

Boston Scientific Device Correction on Certain Pacemakers

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Boston Scientific begins a Class 1 recall (device correction) involving certain pacemakers and cardiac resynchronization therapy p...