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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Eastern Cranial Affiliates, Eminent Spine, Fasprin Health/Nobel Laboratories, HS...

Comments Sought on Corrections & Removals

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Federal Register Notice: FDA seeks comments on Reports of Corrections and Removals 21 CFR Part 806.

Agenda Changed for Oncologic Drugs Panel Meeting

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Federal Register Notice: FDA amends the notice of a 12/2 meeting of the Oncologic Drugs Advisory Committee to postpone a discussio...

Appeals Court Rejects Vermont Doctor Information Law

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A federal appeals court rejects a Vermont law that tried to restrict health information company access to prescribing information.

Merck to Seek FDA Approval for Vytorin Use in Kidney Patients

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Merck says it will seek FDA approval to expand the use of its cholesterol-lowering drug Vytorin for patients with kidney disease a...

Record Year For FDA-related Fines $1.8 Billion

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The U.S. Justice Department says fiscal year 2010 saw a record $1.8 billion in fines, forfeitures, and related actions under the F...

Impax Sued Over ANDA for Generic Welchol Suspension

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Daiichi Sankyo and Genzyme file a patent infringement suit against Impax Laboratories over a recently submittied ANDA for a generi...

Omthera Pharma Gains Protocol Agreement for Epanova Trial

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Omthera Pharmaceuticals and FDA reach agreement on a special protocol assessment on a planned Phase 3 trial involving Epanova for ...

FDA Allows Stem Cell Trial for Macular Degeneration

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FDA approves an Advanced Cell Technology IND to begin a Phase 1-2 multicenter clinical trial using retinal cells derived from huma...

FDA OKs Clinical Testing for OraSure HIV OTC Test

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FDA grants OraSure Technologies an investigational device exemption for the final phase of testing for the OraQuick Rapid HIV-1/2 ...