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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 ...

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...

House Childhood Cancer Caucus Asks About Daunorubicin

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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.

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...

Monitor Compliance Agreements for Enforcement Trends: Posting

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Policy and Medicine urges regulated industry to study new compliance integrity agreements to keep up with enforcement trends.

Analysts See Record Sales for Drugs Approved in 2013

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An EP Vantage report forecasts record post-launch sales for drugs approved this year.

PA Bill Requires Biologic Substitute Notification

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BIO praises a Pennsylvania Senate committee for approving legislation requiring pharmacist notification of biologic product substi...

FDA Approves Another Breakthrough Drug Imbruvica

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FDA approves a second breakthrough-designated drug Pharmacyclics and Janssen Biotechs Imbruvica (ibrutinib) for treating patients...