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FDA OKs Elanco sNADAs for Cattle Feed

[ Price : $8.95]

Federal Register Final rule: FDA approves two Elanco Animal Health supplemental NADAs that provide for administering ractopamine H...

ICH Guidance on Capillary Electrophoresis

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Federal Register Notice: FDA releases an ICH guidance, Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH...

Tougher Accelerated Approval Standards Needed: Lancet

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Lancet Oncology calls for an end to a trend toward lowering the evidence threshold for accelerated drug approvals.

Guidance on the Index of Legally Marketed Unapproved Animal Drugs

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Federal Register Notice: FDA releases a Level 2 guidance: Small Entities Compliance Guide The Index of Legally Marketed Unapprove...

ICH Guidance on Analytical Sieving General Chapter

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Federal Register Notice: FDA releases an IHC guidance: Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH...

Court Rejects Apotex Aricept Suit

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A North Carolina federal court rejects Apotex attempt to block exclusivity for another company for a generic form of Eisais Aricep...

Journal Article Shows Meridia Increases Cardiovascular Risk

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Two weeks before an advisory committee panel will review results from a safety study involving Abbott's weight-loss drug Meridia (...

Crying in the Wilderness Over Food Animal Antibiotics

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FDA Webview consulting editor John Scharmann says that despite rising public opposition to growth-promotion use of antibiotics in ...

FDA Approves Ascension's Total Shoulder System

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FDA approves an Ascension Orthopedics PMA for the Titan Modular Total Shoulder System.

Device Submissions Up, Review Times Down

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CDRHs Office of Device Evaluation says it is making excellent progress in implementing MDUFMA and meeting its performance goals.