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Guidance on H. pylori-Associated Ulcer Treatments

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Federal Register Notice: FDA releases a draft guidance on developing drugs for treating Heliobacter pylori-associated duodenal ulc...

FDAs Culture of Secrecy Will Beat Obama

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FDA Webview editor Jim Dickinson reviews FDAs accelerating record of bureaucratic secrecy against new transparency efforts and con...

FDA Tentative OK for Generic Flomax

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FDA issues a tentative approval for an Impax Laboratories ANDA for a generic version of Boehringer Ingelheim Pharmaceuticals Floma...

Seattle Genetics Halts Lymphoma Trial

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Seattle Genetics stops its SeaGen MARINER clinical trial of dacetuzumab plus other drugs in treating relapsed or refractory diffus...

Wyeth Raises Questions on Postmarketing Studies Guidance

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Wyeth suggests that FDA detail communication requirements for postmarketing requirements and commitments in its draft guidance.

Group Wants FDA Lupus Treatment Steps

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The Lupus Foundation of America says that FDA should take a new look at potential clinical trial designs for drugs to treat lupus.

SciClone Stops Cancer Drug Trial

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SciClone says it is stopping trials of its RP101 for treating late-stage pancreatic cancer.

Docket Number Corrected

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Federal Register Proposed rule: FDA corrects a docket number in a proposed rule on current good manufacturing practice requirement...

Review Period Set for Mercks Emend for Injection

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Federal Register Notice: FDA determines the regulatory review period for Mercks Emend for Injection for the purpose of patent exte...

FDA Slates 2nd Transparency Meeting

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Federal Register Notice: FDA schedules a second public meeting 11/3 to discuss transparency issues at the agency.