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NatureLab Adulterated and Misbranded Dietary Supplements

[ Price : $8.95]

FDA warns Carrollton, TX-based NatureLab about adulterated and mislabeled dietary supplements.

CGMP Violations at Abraxis Bioscience

[ Price : $8.95]

FDA warns Phoenix, AZ-based Abraxis Bioscience about CGMP violations in its manufacturing of finished pharmaceuticals.

ANDA Sameness Evaluation Guidance

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FDA publishes a draft guidance with recommendations on how ANDA applicants can demonstrate sameness between the active ingredient ...

FDA Raises Sabizabulin Uncertainties

[ Price : $8.95]

FDA raises uncertainties with Verus request for Covid-19 treatment emergency use authorization for its repurposed investigational ...

Omeros Loses Appeal on Stem Cell Transplant Drug

[ Price : $8.95]

CDERs Office of New Drugs denies an Omeros appeal of complete response letter on its BLA for narsoplimab as a treatment for hemato...

Review Period for AngelMed Guardian System

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Angel Medical Systems Angel...

Drug-Device Combo Firms Quiz FDA on Specs

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The Combination Products Coalition says its members have several concerns with recent FDA requests for validation of product inter...

Nourianz Regulatory Review Period

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Kyowa Kirins Nourianz (istr...

Start Device Covid Transition Plans Now: Attorneys

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Two Wiley Rein attorneys caution medical device manufacturers to start preparing their transition plans and marketing applications...

FDA Seeks New Accelerated Approval Requirement

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FDA appears to be raising the bar for sponsors seeking accelerated approval by requesting that they be well underway with their Ph...