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FDA publishes a draft guidance revising a recent draft on quality considerations for topical ophthalmic drugs.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

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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...

Hospira Recalls 1 Bleomycin Lot

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FDA says Hospira has recalled one lot of bleomycin for injection following a confirmed report of glass particulate in one vial.

QS Issues at Fresenius Medical Care

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FDA warns Fresenius Medical Care Holdings about Quality System regulations violations in its work as a specification developer for...

East Fork Cultivars Illegal CBD Products

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FDA warns Takilma, OR-based East Fork Cultivars about marketing misbranded unapproved new drugs containing cannabidiol.