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Federal Register notice: FDA posts a guidance on Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations ...[ Price : $8.95]
CDER says it will develop a guidance this year on Comparative Analyses of the Device Constituent of a Drug-Device Combination Prod...[ Price : $8.95]
FDA posts a guidance on Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Huma...[ Price : $8.95]
Novocure says a long-term survival analysis of data from a Phase 3 (EF-14) trial of Optune in combination with temozolomide confir...[ Price : $8.95]
The Washington DC District Court rules against FDA in granting a Ferring motion for reconsideration over how FDA decided not to re...[ Price : $8.95]
Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budge...[ Price : $8.95]
Federal Register notice: FDA releases a draft guidance on 510(k) Third Party Review Program.[ Price : $8.95]
Federal Register notice: FDA seeks nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee.