FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

GPhA Asks Many Questions About Stability Guidance

[ Price : $8.95]

The Generic Pharmaceutical Association asks FDA many questions about its draft guidance on stability testing for ANDAs.

CDER Opens Web Page for IND Investigators

[ Price : $8.95]

CDER launches a Web navigational tool for academic investigators working on IND applications.

Comments Sought on Therapeutic Area Standards Plan

[ Price : $8.95]

FDA releases for comment the Therapeutic Area Standards project plan for PDUFA 5 drug and biologic clinical terminology standards....

Public Citizen Wants to Silence Advisory Committee Chair

[ Price : $8.95]

Public Citizen wants a ban on FDA advisory committee members making presentations to industry on how best to get a favorable decis...

U.S. Oncology, BioMarin Begin Phase 3 Study in BRCA Breast Cancer

[ Price : $8.95]

U.S. Oncology Research and BioMarin Pharmaceutical collaborate to launch a Phase 3 study of BMN 673, a poly ADP-ribose polymerases...

FDA Releases Therapeutic Area Standards Plan

[ Price : $8.95]

Federal Register Notice: FDA makes available the Therapeutic Area Standards Initiative Project Plan.

Guidance on Nucleic Acid Tests to Reduce West Nile Virus

[ Price : $8.95]

Federal Register Notice; FDA releases a draft guidance on the use of nucleic acid tests to reduce the transmission of West Nile Vi...

Guidance on Active Control Animal Drug Studies

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for...

Panel to Discuss Vandas NDA for Sleep-Wake Disorder

[ Price : $8.95]

Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 11/14 to discuss a Vanda Ph...

Public Meeting on Meta-Analyses to Assess Trial Safety

[ Price : $8.95]

Federal Register Notice: FDA plans a public meeting 11/25 to obtain input on using meta-analyses of randomized controlled clinical...