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On a CDER guidance recap podcast, master mathematical statistician James Travis explains a new draft guidance on using Bayesian me...[ Price : $8.95]
FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed to consider a proposal from i...[ Price : $8.95]
The FY 2025 report on GDUFA-funded science and research tells how the research supported the development of product-specific guida...[ Price : $8.95]
USC associate professor Genevieve Kanter says she is skeptical that the wholesale firing of HHS advisory committee experts to elim...[ Price : $8.95]
The National Association of Manufacturers calls on FDA to adhere to statutory and regulatory provisions governing expert panel mee...[ Price : $8.95]
An advocacy group takes aim at FDA, arguing in a new report that the agencys drug review process has grown more costly and restric...[ Price : $8.95]
Kodiak Sciences says its anti-VEGF therapy Zenkuda (tarcocimab tedromer) hit the mark in a second Phase 3 trial in diabetic retino...[ Price : $8.95]
Health experts breakdown a new FDA policy framework that could mark a turning point for highly individualized genetic medicines.