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PhRMA Wants Kickback Decision Reconsidered

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PhRMA says a Massachusetts federal court should certify for appeal its flip-flop decision that ultimately ruled that CCS Medical S...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Ajes Pharmaceuticals, Cheng Fong Chemical Co., and Elite Laboratories.

Differentiating Literally False and Impliedly False Ads

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Attorney Sandra Edelman describes the legal distinction applied by the 2nd Circuit Appeals Court in determining whether an adverti...

CGMP Violations at Cheng Fong Chemical

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FDA warns Chinas Cheng Fong Chemical CGMP violations in its production of active pharmaceutical ingredients.

Elite Laboratories PADE Reporting Violations

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FDAs New Jersey District Office warns Elite Laboratories about its failure to implement Postmarketing Adverse Drug Experience repo...

FDA, EMA Rare Diseases Cluster

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FDA and the European Medicines Agency agree on operating procedures for a new joint cluster on rare diseases.

Notice on Biomarkers Listing Corrected

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Federal Register Notice: FDA corrects a 9/19 notice entitled "A List of Biomarkers Used as Outcomes in Development of FDA-Approved...

Janssen Files Imbruvica sNDA for Lymphoma

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Janssen Research & Development files a supplemental NDA for Imbruvica (ibrutinib) for treating patients with marginal zone lymphom...

Public Meeting for Generic Drug User Fee Reauthorization

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Federal Register Notice: FDA announces a public meeting to discuss proposed recommendations for reauthorizing the Generic Drug Use...

FDA Clears Roche 510(k) for Syphilis Assay

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FDA clears a Roche 510(k) for the Roche Syphilis treponemal antibody test, a fully automated assay for detecting antibodies to Tre...