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FDA Faults Revonto Web Page

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says that a Web page for US WorldMeds Revonto misleadingly says it is superior to othe...

United Wants Safety Info in Generic Remodulin Label

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United Therapeutics asks FDA not to allow ANDAs for generic Remodulin injection that carve out important safety information.

Internet Unapproved Drug Sellers Threaten Public Health: NABP

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The National Association of Boards of Pharmacy warns of the continuing global public health threat due to Internet sales of unappr...

Suits Seen as Likely Over Changes Being Effected Proposal

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Attorneys say generic drug companies are likely to sue FDA over its proposed rule to allow them to file labeling changes being eff...

Comments Sought on Dietary Ingredient Info

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Federal Register Notice: FDA seeks public comments on information collection provisions for petitions requesting an exemption from...

Comments Sought on Patent Regulations & FDA Review Time

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Federal Register Notice: FDA seeks comments on its patent term restoration regulations and petitions for regulatory review period ...

House Childhood Cancer Caucus Asks About Daunorubicin

[ Price : $8.95]

The co-chairs of the congressional Childhood Cancer Caucus ask FDA commissioner Margaret Hamburg what the agency is doing to elimi...

P&G Wants Equivalent OTC Prilosec Labeling

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Procter & Gamble asks FDA to ensure that labeling for any OTC proton pump inhibitor is similar to that approved for Prilosec OTC.

AstraZeneca Plans 2 More Brilinta Studies

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AstraZeneca plans to begin two new clinical trials of its Brilinta in patients who have had an acute ischemic stroke or TIA and in...

Senate to Debate Compounding Bill

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Sen. Tom Harkin says the Senate will debate his Drug Quality and Security Act on oversight of drug compounding and a national drug...