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Zenrelia Promotions False and Misleading: FDA

[ Price : $8.95]

FDA warns Elanco Animal Health that promotional materials for its Zenrelia are misbranded due to false and misleading representati...

FDA Safety Alert on Immune Globulin Products

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An FDA safety alert says several manufacturers have recalled several lots of immune globulin intravenous and subcutaneous products...

CGMP Deviation in Chemspec Chemicals Inspection

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FDA cautions Indias Chemspec Chemicals about a CGMP deviation in its production of active pharmaceutical ingredients.

7 Acne Products Recalled for Benzene: FDA

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FDA says manufacturers are recalling seven acne products containing benzoyl peroxide to the retail level after testing found possi...

Regulate NarxCare as Software as Medical Device: Petition

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The Doctor Patient Forum petitions FDA to regulate Bamboo Healths NarxCare platform and other prescription drug monitoring program...

Top Device Science Official Leaves FDA

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CDRH chief scientist and deputy Center director Doug Kelly abruptly resigns after less than five years at the agency.

CGMP Deviations at Shree Jaya Unit

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FDA warns Indias Shree Jaya Laboratories about CGMP deviations in its production of active pharmaceutical ingredients at a facilit...

Linghai ZhanWang Records Show CGMP Violations

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FDA warns Chinas Linghai ZhanWang Biotechnology Co. about CGMP violations in its manufacturing of over-the-counter drugs.

Positive Data on Pfizer/Arvinas Breast Cancer Study

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Pfizer and Arvinas announce positive topline results from a clinical trial evaluating vepdegestrant monotherapy versus fulvestrant...

FDA Rejects All Mid-Link Technology Data

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FDA tells Chinas Mid-Link Technology Testing Co. it is rejecting all data from all studies conducted by the company until it provi...