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Info Collection Extension for CLIA Waivers

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension for Clinical Laboratory Improvement Amendments wai...

Sharpless Outlines Key Priorities for FDA

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FDA acting commissioner Ned Sharpless outlines key agency priorities that include supporting emerging technologies, investing in t...

Jubilant Cadista Recalls 1 Contraceptive Lot

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Jubilant Cadista Pharmaceuticals recalls one lot of drospirenone and ethinyl estradiol tablets due to out-of-specification dissolu...

WHO Quality Management Draft Requirements

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The World Health Organization releases for comment a working document on quality management system requirements for national regul...

Praise, Suggestions for Therapeutic Protein Biosimilar Guidance

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Five stakeholders express appreciation for an FDA draft guidance on considerations for developing therapeutic protein biosimilars ...

Grassley, Wyden Push Drug Price Overhaul Bill

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The Senate Finance Committee will mark up a bipartisan prescription drug pricing overhaul bill sponsored by Sens. Grassley and Wyd...

CGMP, Other Violations at Indoco Remedies Goa

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FDA warns Indias Indoco Remedies Limited about CGMP and other violations at its Goa drug manufacturing facility.

Court Orders FDA Reconsideration of Brixadi Application

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The DC federal court says FDA should reconsider its exclusivity decision for Indiviors Sublocade that blocked Braeburns Brixadi fr...

CGMP Deviations in High Chemical Inspection

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FDA warns High Chemical about CGMP deviations in its production of active pharmaceutical ingredients.

Warning Issued to CBD Maker Over Illegal Claimsֺ

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FDA issues a Warning Letter to Curaleaf (Wakefield, MA) for illegally selling unapproved products containing cannabidiol online wi...