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Guide on Product Manufacturing Discontinuance

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance on notifying FDA about a permanent discontinuance or interruption in produ...

Ophthalmic Panel Review VisAbility Micro Insert PMA

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Federal Register notice: FDA announces a 6/8 ophthalmic devices advisory committee meeting that will review a Refocus Group PMA fo...

CGMP Violations at Bulgarias Ficosota

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FDA warns Bulgarias Ficosota drug manufacturing firm about CGMP violations in its production of finished drugs.

Multiple Violations at Trilogy Laboratories

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FDA warns Trilogy Laboratories about CGMP, new drug, and misbranding violations in its production of finished drugs.

End Clozapine REMS: Psychiatrist

[ Price : $8.95]

Psychiatrist David Behar petitions FDA to remove the clozapine REMS program and allow providers to use their clinical judgment in ...

Pfizer Healthcare India CGMP Violation

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FDA warns Pfizer Healthcare India about a CGMP violation in its production of finished drugs.

CME BodyGuard Infusion Pump Recalled

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CME America recalls the BodyGuard Infusion Pump Systems because the pumps may under or over infuse medications.

PhRMA Rare Disease Day Comments

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PhRMA submits additional comments on the FDA 2/24 Rare Disease Day public meeting.

Novartis Not Penalized for Zolgensma Violations

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FDA ends its probe of Novartis Zolgensma data manipulation and waives any regulatory action against the company.

Court Backs Vascepa ANDAs

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Nevadas federal court rules against Amarin in a patent dispute with two generic drug companies over its Vascepa heart drug.