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FDA Pitches QbD to Small Business to Improve Quality

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A new FDA publication makes a pitch to small businesses for improved drug quality through a quality-by-design approach.

FDA Clears K2M Spinal Systems for Scoliosis in Adolescents

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FDA grants clearance to K2M, Inc. for its MESA Deformity, Mesa Rail Deformity, MESA Small Stature, and MESA Rail Small Stature Spi...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Fercy Personal Care Products, Mir-Com Products, Naturavit, and Olympus Gyrus ACM...

FDA Corrects Notice on Tobacco Establishment Registration

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Federal Register Notice: FDA corrects a 5/3 Federal Register notice on registration and product listing for tobacco product establ...

FDA Corrects Notice on Tobacco Ingredients

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Federal Register Notice: FDA corrects form numbers in an 8/3 Federal Register notice on tobacco product ingredients listings.

Researchers Urge Re-examination of Taxane Chemo Drug Activity

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Researchers at Weill Cornell Medical College say taxane-based chemotherapy drugs may be misunderstood and underestimated and shoul...

PMA Application Pulled for Ponatinib Companion Test

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MolecularMD withdraws its PMA application for the BCR-ABL T3151 mutation test which was used in conjunction with Ariads ponatinib....

FDA Approves Nuvail for Nail Dystrophy

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FDA approves Innocutis Nuvail (poly-ureaurethane, 16%) nail solution, a prescription product intended to help manage fragile or br...

Inspection Finds Gyrus Quality System Problems

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FDAs New England District Office warns Gyrus ACMI about Quality System Regulation violations in its manufacturing of the D-DUR ure...

Dont Use Intestinomicina: FDA

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FDA warns against using chloramphenicol-containing Intestimonicina for diarrhea.