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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

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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.

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...

Alkermes Seeks Bioquivalence Guidance Changes for Risperidone

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Alkermes asks FDA to amend its draft bioequivalence recommendations for risperidone intramuscular injection (Janssens antipsychoti...

CDER Regulatory Flexibility Lags in Quality-by-Design Initiative

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CDER Office of New Drug Quality Assessment acting director Christine Moore says that while quality-by-design principles have been ...

FDA Denies Hearing, Debars Diamond

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Federal Register Notice: FDA denies a request from Bruce I. Diamond for a hearing and is debarring him from providing services to ...

Comment Period Reopened on Medical Foods Guidance

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Federal Register Notice: FDA reopens the comment period on a draft guidance entitled Frequently Asked Questions About Medical Food...