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FDA Releases Bioequivalence Recommendations

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Federal Register Notice: FDA releases additional product-specific bioequivalence recommendations.

Comments Sought on CLIA Waivers

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Federal Register Notice: FDA seeks comments on collections of information associated with Clinical Laboratory Improvement Amendmen...

Comments Sought on Electronic Submission Gateway

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Federal Register Notice: FDA seeks comments on the use of the FDA Electronic Submission Gateway and the Safety Reporting Portal to...

Proteonomix, University Plan Phase 1 Trial in Liver Disease

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Proteonomix, Inc. and University of Medicine and Dentistry of New Jersey agree to conduct a Phase 1 clinical trial to study the fi...

FDA Records Sponsor Change for 3 ANADAs

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Federal Register Final rule: FDA amends the animal drug regulations to reflect a change of sponsor for 3 ANADAs to Phibro Animal H...

Survey Encourages Distinct Biosimilar Naming

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A survey by the Alliance for Safe Biologic Medicines indicates that physicians would like to see distinct names for approved biosi...

Advisors Recommend Against Lixivaptan Approval

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Members of FDAs Cardiovascular and Renal Drugs Advisory Committee say that Cornerstones NDA for lixivaptan should not be approved....

FDA Investigators Looking Closely at Sampling/Testing Programs

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FDA consumer safety officer Brooke Higgins tells a conference session that FDA investigators are spending more time during drug pr...

FDA Sets Fee for Tropical Disease Priority Review

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Federal Register Notice: FDA sets the fee rate for using a tropical disease priority review voucher for fiscal year 2013.

FDA Permanently Debars Spencer

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Federal Register Notice: FDA permanently debars Wayne E. Spencer from providing services to any person with an approved or pending...