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Guidance on OTC Drug Labeling

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Federal Register Notice: FDA releases a revised draft guidance on the labeling of nonprescription human drugs products marketed wi...

FDA OKs Ivy Labs sANADA

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Federal Register Final rule: FDA approves an Ivy Labs sANADA for increased levels of monensin in Type C medicated feeds for heifer...

Advisors Want Asthma Drug Restrictions

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FDA advisors say risks associated with asthma drugs Serevent and Foradil outweigh benefits for most patients.

Its Official, Daschle Nominated to Head HHS

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President-elect Barack Obama officially nominates former senator Tom Daschle (D-SD) as Health and Human Services secretary.

Why Did FDA Wait 6 Months to Seize Bad Heparin?

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Rep. Barton asks why FDA waited six months to seize contaminated heparin after twice warning the manufacturer that its recall effo...

PhRMA Issues Strengthened DTC Principles

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PhRMA revises its DTC Guiding Principles and will release names of companies promising to comply.

FDA Panel Backs Genzymes Synvisc-One

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An FDA advisory committee recommends approval of Genzymes Synvisc-One, intended for use in relieving pain associated with osteoart...

Advisors Nix Acuspheres Imagify

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FDAs Cardiovascular and Renal Drugs Advisory Committee says Acuspheres Imagify doesnt offer enough benefit to overcome its risks....

2 Clinical Trial Withdrawal Guidances

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FDA and HHS issue guidances on use of data when a subject is no longer participating in a clinical trial.

PMA Supplement Guidance Out

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CDRH issues a guidance to help sponsors determine the type of regulatory submission needed to modify a lawfully marketed PMA devic...