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Guidance on Vet Med Adverse Event Terms

[ Price : $8.95]

CVM issues a final harmonized guidance on terms for use in reporting animal medicine adverse events.

FDA Speeding Medical Device Reviews: Hamburg

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FDA commissioner Margaret Hamburg says her agency is developing ways to speed promising medical devices through a robust regulator...

Consolidated BIMO Program Under Consideration at FDA

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FDAs Program Alignment directive aims to re-shape bioresearch monitoring (BIMO) inspections by creating a dedicated corps of ORA s...

Stronger Chantix Label Sought

[ Price : $8.95]

Five consumer and medical advocacy organizations call on FDA to strengthen safety warnings in the Chantix labeling.

Comments Sought on Patient-Focused Drug Development

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on its patient-focused drug development initiative.

OMB OKs Info General Administrative Procedures

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on citizen petitions, petit...

Lupron Depot Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Lupron Depot Injectable 3.75 mg/vial was not withdrawn from sale for reasons of safet...

Guidance on Drug Product Tracing/Distributor Licensing

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Federal Register Notice: FDA releases a draft guidance on the effect of the FD&C Act Section 585 on drug product tracing and whole...

Committee to Discuss Soliris REMS

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Federal Register Notice: FDAs Drug Safety and Risk Management Advisory Committee will meet 11/18 to discuss.

Regen Bio Files IND for dCellVax in Breast Cancer

[ Price : $8.95]

Regen BioPharma files an IND with FDA to begin a clinical trial of dCellVax in patients with metastatic breast cancer.