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Droperidol Warning Unnecessary Researchers Say

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A new epidemiological study suggests that a 2001 arrhythmia warning on droperidol may be unnecessary.

FDA Accepts The Medicines Co. sNDA for Angiomax

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FDA accepts a supplemental NDA from The Medicines Company for a modified dosing regimen of Angiomax for treating acute coronary sy...

CDRH Turnover and Consistency Top Questions at RAPS

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Staff turnover and consistency concerns top the questions on the minds of industry after a CDRH executive briefing during the Regu...

FDA Corrects Error in Blood Products Rule

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Federal Register Proposed rule: FDA corrects typographical errors on an 8/16 Federal Register proposed rule that updates regulatio...

FDA Says Company Manipulated Test Results

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FDA investigators are looking into whether Leiner Health Products committed criminal violations at its Fort Mill, SC, manufacturin...

Device Companies Prefer Conservative DTC

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Experts disagree on the role of DTC ads for medical devices and whether companies will try more aggressive DTC spots.

DTC Restrictions Beaten Back

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Advertising and media companies work with drug companies to eliminate the most onerous DTC restrictions from FDA reform legislatio...

CGMP Problems at Chinese Drug Company

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FDA warns Chinas Kunshan Chemical and Pharmaceutical Company about CGMP violations at its API manufacturing facilities.

OMB OKs Info on Pharma Development Study

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on pharmaceutical developme...

Comments Sought on Radioactive Drugs Regs

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Federal Register Notice: FDA seeks comments on regulations governing the use of radioactive drugs for basic informational research...