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No-holds-barred Marketing Questions Pummel FDAers at FDLI

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FDA officials respond to a barrage of questions on achieving compliance for advertising/promotional materials, at the concluding s...

Latest FDA Inspection Reports Posted

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We post to our Web site latest FDA-483 documents we have received pursuant to our FOI requests for Bausch & Lomb, Greenville, SC; ...

FDA Bans Flavored Cigarettes

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FDAs Center for Tobacco Products announces an immediate ban on manufacturing, shipping, and marketing cigarettes with fruit, candy...

Panel to Discuss Spiriva Handihaler for COPD Exacerbations

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Federal Register Notice: FDAs Pulmonary-Allergy Drugs Advisory Committee will meet 11/19 to discuss Boehringer Ingelheims sNDA for...

FDA Warns on Choking Hazard with Help Button

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FDA warns about a choking hazard associated with Philips Lifelines Personal Help Buttons that are worn around the neck.

FDA Lying to Protect Mercury Amalgam Industry: Petition

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A lawyers petition to FDA to reconsider its controversial dental mercury amalgam final rule accuses the agency of using its Web si...

Reformulated OxyContin May Discourage Dose Dumping

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An FDA staff review says that a reformulated version of OxyContin may offer some additional protections against abuse.

CDER Compliance Deputy Famulare Retiring

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CDER Office of Compliance deputy director Joe Famulare announces his retirement effective 9/30 after 32 years at the agency.

Panel to Vote on Thermoplasty System for Asthma

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Federal Register Notice: FDAs Anesthesiology and Respiratory Therapy Devices Panel will meet 10/28 to vote on an Asthmatx, Inc. PM...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Continuum Health Partners and Therasage.