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Cell/Gene Product Potency Assurance

[ Price : $8.95]

FDA publishes a draft guidance on developing a science- and risk-based strategy to help assure the potency of a human cellular the...

CGMP Violations at Patco Cosmetics

[ Price : $8.95]

FDA warns Indias Patco Cosmetics about CGMP violations in its manufacturing of finished over-the-counter drugs.

Dont Use Counterfeit Ozempic: FDA

[ Price : $8.95]

FDA says it has seized thousands of units of counterfeit Ozempic that also contain counterfeit needles.

Califf Discusses More Clinical Research Options

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FDA commissioner Robert Califf says a new final rule allowing some waivers of informed consent will enable minimal-risk research t...

Topical Ophthalmic Quality Guidance

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FDA publishes a draft guidance revising a recent draft on quality considerations for topical ophthalmic drugs.

CGMP Violations in Omeza Inspection

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FDA warns Sarasota, FL-based Omeza about CGMP violations in its production of unapproved and misbranded over-the-counter drugs.

2nd CRL for Mercks Gefapixant Chronic Cough Drug

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FDA issues a complete response letter for the Merck resubmitted NDA for gefapixant, saying the drug did not establish substantial ...

Medline Recalls Trach Care and Cleaning Trays

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Medline Industries recalls some lots of tracheostomy care and cleaning trays following complaints.

Insight Recalls 1 Lot of Americaine Topical Spray

[ Price : $8.95]

FDA says Insight Pharmaceuticals is recalling one lot of its Americaine benzocaine topical anesthetic spray due to the presence of...

Hua Da Trading Selling Unapproved Viagra: FDA

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FDA warns Brooklyn, NY-based Hua Da Trading that it is illegally marketing a misbranded unapproved drug containing the active ingr...