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FDA-backed Critical Path Institutes Transplant Therapeutics Consortium submits the iBox Scoring System for CDERs Biomarker Qualifi...[ Price : $8.95]
FDA says it is participating in a new Diagnostics Evidence Accelerator focusing on using real-world data to answer questions about...[ Price : $8.95]
FDA updates its list of off-patent, off-exclusivity drugs for which there is no approved generic product.[ Price : $8.95]
CDER issues a MAPP with procedures for determining the need for and components of a new REMS for drug products approved through an...[ Price : $8.95]
A petition to FDA submitted by a physician asks the agency to include in opioid Boxed Warnings and package inserts HHS language en...[ Price : $8.95]
Former FDA acting chief scientist Luciana Borio tells Barrons FDA leadership needs to work to regain public trust so that people w...[ Price : $8.95]
FDA approves an Ultragenyx Pharmaceutical and Kyowa Kirin supplemental BLA for Crysvita (burosumab) for treating fibroblast growth...[ Price : $8.95]
FDA approves a label update for Almiralls Seysara (sarecycline) stating that P. acnes strains displayed a low propensity for devel...